MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® IMPLANT 5 X 10MM; DENTAL IMPLANT

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being submitted to report (b)(4).The reported device has been received for evaluation.Investigation has not yet begun.Once investigation has been completed, a follow up medwatch will be submitted.
Event or Problem Description
It was reported that the implant at tooth location 46 was removed due to bone loss.
Event or Problem Description
No additional or corrected information to report.
Additional Manufacturer Narrative
This report is being submitted to relay additional information.The following sections are being reported: b4: date of this report was updated.D4: expiration date and unique identifier (udi) number were added.G4: date received by manufacturer was updated.G7: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H4: device manufacturer date was updated.H6: method code was updated to 3331 and 4109.H6: results code was updated to 213.H6: conclusions code was updated to 4310.H10: narrative/data was updated.The reported device was received for evaluation.The reported medical condition of bone loss was not confirmed.Visual inspection of the as returned product identified wear and debris about the implant threads.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.A device history record (dhr) review was completed for the reported device lot.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance, which could have caused or contributed to the reported event was noted as part of the dhr.A complaint history review was completed for the reported device lot for similar event and no other complaint was identified.A definitive root cause for the reported event could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OSSEOTITE® IMPLANT 5 X 10MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9262618
• Report Number: 0001038806-2019-01294
• Device Sequence Number: 13923133
• Product Code: DZE
• UDI-Device Identifier: 00844868013259
• UDI-Public: (01)00844868013259(17)190122(10)2014010304(241)OSS510
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/22/2019
• Device Model Number: N/A
• Device Catalogue Number: OSS510
• Device Lot Number: 2014010304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention