MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE CERTAIN 2 IMPLANT 4 X 10MM; DENTAL IMPLANT

Model Number	XIFOSS410
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).
Event or Problem Description
Doctor reported the implant fractured and was removed.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).An osseotite® certain® 2 implant 4 x 10mm (xifoss410) and an osseotite® certain® 2 implant 4 x 11.5mm (xifoss411) were returned for investigation.Visual inspection of the as returned products identified worn markings due to usage, dried blood and bine.Also a fracture on the threads.Device history record (dhr) review was completed for the subject lot numbers (2013050052 and 2013100671).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2013050052 and 2013100671) for similar event and no other complaint was identified.Based on the available information, device malfunction could not be verified for the xifoss411, however device malfunction for xifoss410 did occur and the reported event is confirmed.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: OSSEOTITE CERTAIN 2 IMPLANT 4 X 10MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10957197
• Report Number: 0001038806-2020-01989
• Device Sequence Number: 2419329
• Product Code: DZE
• UDI-Device Identifier: 00844868023142
• UDI-Public: (01)00844868023142(17)180514(10)2013050052(241)XIFOSS410
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K100724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/14/2018
• Device Model Number: XIFOSS410
• Device Catalogue Number: XIFOSS410
• Device Lot Number: 2013050052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Weight: 85