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This submission is for the 1q18 asr serious injury events for endosseous dental implants under asr exemption # 1997021.This report summarizes 4993 serious injury events where patient's experienced endosseous dental implant failure (patient problem code: 1924).Of these events there were:
343 events where erosion occurred (patient problem code: 1750).8 events where tissue damage occurred (patient problem code: 2104).651 events where inflammation occurred (patient problem code: 1932).757 events where infection occurred (patient problem code: 1930), of which 1 event where an abscess occurred (patient problem code: 1690).395 events where patient's experienced osteolysis (patient problem code: 2377).5 events where patient's experienced sinus perforation (patient problem code: 2277).21 events where patient's experienced pain (patient problem code: 1994).2 events where patient's experienced numbness (patient problem code: 2415).3 events where patient's experienced swelling (patient problem code: 2091).1 event where a patient experienced necrosis (patient problem code: 1971).2 events where device fragments remain in patients (patient problem code: 3165).1172 events were due to loss of osseointegration (device problem code: 2408).2267 events were due to the device failing to osseointegrate (device problem code: 1863)
in 1079 events, there was no known device problem reported (device problem code: 2993).376 events involved fracture of the device or a component (device problem code: 1260).40 events involved an improper or incorrect procedure or method (device problem code: 2017).In 16 events, the device was malpositioned (device problem code: 2616).35 events involved a failure to separate of a device or a component (device problem code: 2547).In 12 events it was reported the device was difficult to position (device problem code: 1467).In 10 events it was reported that the device material torqued (device problem code: 2980).In 2 events, migration of the device or component occurred ((device problem code: 1395).In 21 events it was reported that the device cracked (device problem code: 1135).In 2 events, a mechanical issue was reported (device problem code: 1384).In 1 event, the user used the incorrect product for intended use (device problem code: 1494).In 3 events, there is no information regarding the device failure despite multiple attempts to obtain the information.In 4973 events, evalatuion concluded that this was a known inherent risk of the procedure.In 21 events, devices were received in a condition making evaluation impossible.In 16 events, devices could not be evaluated because the incomplete device was returned.In 416 events, evaluation found that the operational context caused or contributed to the event.In 32 events, evaluation found the clinician failed to follow instructions.In 30 events, evaluation found there was off-label, unapproved or contraindicated use.In 43 events, evaluation found a user error caused or contributed to the event.In 811 events, evaluation determined that device failure was related to the patients conditions.14 devices were evaluated and found to be within specification.242 devices were not returned for evaluation.
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