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facial stimulation, itching), and decrease in the patient's hearing performance. When such symptoms occur, the patient's clinical team evaluates the patient and the device using in-situ methods, and determines if revision surgery is necessary. The most commonly reported device failures are due to impacts, loss of hermeticity, and electrode lead malfunctions. Most manufacturers provide on their websites the survival rate of their marketed implants, although they are not required to do so. In order to improve and standardize failure reporting practices to the public, the AAMI is developing an
American standard for cochlear implants in collaboration with the FDA, major cochlear implant manufacturers, the
172:, and Dr. Steven Nissen of the Cleveland Clinic, published in the Archives of Internal Medicine, showed that most medical devices recalled in the last five years for "serious health problems or death" had been previously approved by the FDA using the less stringent, and cheaper, 510(k) process. In a few cases the devices had been deemed so low-risk that they did not need FDA regulation. Of the 113 devices recalled, 35 were for cardiovascular issues. This may lead to a reevaluation of FDA procedures and better oversight.
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related failure (lead migration, lead fracture, ventricular perforation), unit malfunction (battery failure or component malfunction), problems at the insertion site (infections, tissue breakdown, battery pack migration), and failures related to exposure to high voltage electricity or high intensity microwaves.
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Cochlear implants are used to treat severe to profound hearing loss by electrically stimulating the hearing nerve. Clinical symptoms of cochlear implant failure include auditory symptoms (tinnitus, buzzing, roaring, popping sounds), non-auditory symptoms (pain, shocking sensation, burning sensation,
136:
Failure of a dental implant is often related to the failure of the implant to osseointegrate correctly with the bone, or vice versa. A dental implant is considered to be a failure if it is lost, mobile or shows peri-implant (around the implant) bone loss of greater than 1.0 mm in the first year
108:
Pacemaker failure is the inability of an implanted artificial pacemaker to perform its intended function of regulating the beating of the heart. It is defined by the requirement of repeat surgical pacemaker-related procedure after the initial implantation. Causes of pacemaker failure included: lead
71:
by the body, which may function as a favorable medium for bacteria growth. Implant failure due to bacterial infection of the implant can occur at any point of implant lifetime. Bacteria may already reside on the implant or be introduced during the implantation. Typical failure mechanisms include
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habitually prior to having dental implants are significantly more likely to have their implants fail. Individuals who have diabetes and those who disregard general oral hygiene are also at higher risk of having their implants fail.
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to meet the claims of its manufacturer or the health care provider involved in its installation. Implant failure can have any number of causes. The rates of failure vary for different implants.
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Papageorgiou, S. N.; Zogakis, I. P.; Papadopoulos, M. A. (2012). "Failure rates and associated risk factors of orthodontic miniscrew implants: A meta-analysis".
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233:; Patrick J; Payne SL; Telischi FF; Tobey EA; Truy E; Staller S (2005). "Cochlear implant soft failures consensus development conference statement".
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Galagali, Girish; Reddy, E. Srinivas; Nidawani, Prakash; S P Behera, Sidhartha; Preetham, Pavan; Sarpangala, Mythri (January–March 2014).
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Implant failure can occur due to the degradation of the material an implant is made of. With time, mechanical degradation, in the form of
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Balkany TJ; Hodges AV; Buchman CA; Luxford WM; Pillsbury CH; Roland PS; Shallop JK; Backous DD; Franz D; Graham JM; Hirsch B; Luntz M;
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Tissue-integrated prostheses :osseointegration in clinical dentistry, Per-Ingavar
Branemark, George A. Zarb, Tomas Albrektsson, 1985
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Wagenberg, B.; Froum, S. J. (2006). "A retrospective study of 1925 consecutively placed immediate implants from 1988 to 2004".
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643:
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Moy, P. K.; Medina, D.; Shetty, V.; Aghaloo, T. L. (2005). "Dental implant failure rates and associated risk factors".
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shared documents which indicated that 40% of a class of hip replacement implants which it manufactured had failed.
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393:"Faulty medical implants investigation: Patients failed by poor implant regulation, say surgeons - Telegraph"
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277:"Association for the Advancement of Medical Instrumentation : CI - Cochlear Implants Committee"
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De Bruyn, H.; Collaert, B. (1994). "The effect of smoking on early implant failure".
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De Bruyn, H.; Collaert, B. (1994). "The effect of smoking on early implant failure".
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The monitoring of the safety of implants is conducted within the context of broader
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Tang, L.; Eaton, J. W. (1995). "Inflammatory responses to biomaterials".
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called for increased regulation of implants to prevent implant failure.
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tissue damage and implant detachment due to bacteria generated biofilm.
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International
Journal of Preventive & Clinical Dental Research
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Implants, made of synthetic materials, are naturally coated by a
59:, particularly in metal implants, can arise due to ion release.
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491:"Four Medical Implants That Escaped FDA Scrutiny - ProPublica"
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American
Journal of Orthodontics and Dentofacial Orthopedics
191:"Maker Aware of 40% Failure in Hip Implant - NYTimes.com"
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implants can fail. Outcomes are normally recorded in a
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Dental implant failures have been studied. Persons who
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2011 United States government report on implant safety
446:"Medical Device Recalls and the FDA Approval Process"
122:center for reliability, doctors, and clinicians.
51:, or electrochemical degradation, in the form of
170:National Research Center for Women and Families
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391:Watt, Holly; Newell, Claire (24 Oct 2012).
137:and greater than 0.2 mm a year after.
300:"Implant Failures: A Comprehensive Review"
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87:to ensure patterns are picked up upon.
566:American Journal of Clinical Pathology
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155:Royal College of Surgeons of England
247:10.1097/01.mao.0000178150.44505.52
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549:10.1034/j.1600-0501.1994.050410.x
370:10.1034/j.1600-0501.1994.050410.x
189:Meier, Barry (22 January 2013).
537:Clinical Oral Implants Research
489:Groeger, Lisa (30 April 2012).
358:Clinical Oral Implants Research
159:British Orthopaedic Association
1:
463:10.1001/archinternmed.2011.30
450:Archives of Internal Medicine
19:refers to the failure of any
149:Responses to implant failure
607:10.1016/j.ajodo.2012.05.016
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85:joint replacement registry
444:Zuckerman, Diana (2011).
113:Cochlear implant failure
76:Hip replacement failure
34:Common types of failure
578:10.1093/ajcp/103.4.466
168:and Paul Brown of the
132:Dental implant failure
126:Dental implant failure
92:Johnson & Johnson
309:. 2014, 1(1): 11–17.
164:A 2011 study by Dr.
39:Material degradation
644:Implants (medicine)
398:The Daily Telegraph
63:Bacterial infection
425:on 25 October 2012
281:standards.aami.org
196:The New York Times
601:(5): 577–595.e7.
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98:Pacemaker failure
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501:on 4 June 2013
495:propublica.org
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231:Niparko JK
176:References
411:0307-1235
209:0362-4331
53:corrosion
615:23116500
528:16519184
472:21321283
419:49632006
343:16161741
263:23950969
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201:New York
157:and the
153:In 2012
90:In 2013
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259:S2CID
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507:2013
468:PMID
431:2013
415:OCLC
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374:PMID
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