Device Problem
Fracture (1260)
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Patient Problem
No Information (3190)
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Event Date 09/23/2019 |
Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet complaint number (b)(4).A previous report was submitted under 0002023141-2020-01870 with incorrect mfr number.
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Event Description
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It was reported that the doctor wanted to restore the implant, but was unable to remove the screws with our srt drill and the implant was removed.On a follow up, it was also reported that the abutment screw got stuck inside the implant.Abutment screw fractured and implant at tooth site 19 was removed.Patient has been rescheduled for new implant placement.
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Manufacturer Narrative
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Zimmer biomet complaint number one full osseotite® certain® implant 5 x 10mm (ifos510) and one unknown biomet screw were returned for investigation.Visual evaluation of the as returned products identified screw fragment in the drive feature of an implant that was severely fractured and damaged.Device history record (dhr) & complaint history review (unknown biomet screw): dhr and complaint history review could not be performed as the lot/item number was not available.However, zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products within specifications.Therefore, based on the available information, device malfunction did occur and the reported events were confirmed.
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Event Description
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No further event information is available at the time of this report.
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Search Alerts/Recalls
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