MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE IMPLANT 3.75 X 8.5MM; DENTAL IMPLANT

Model Number	OSS385
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Weight unknown / not provided.
Event or Problem Description
Doctor reported the implant fractured in tooth location 35 and was removed.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number cmp-(b)(4).One osseotite® implant (oss385) was returned for investigation.Visual evaluation of the as returned product identified that it was fractured at the external hex.A damaged crown was also returned but there were no allegations against it (damage probably occurred during the removal process).Device history record (dhr) review was completed for the subject lot number (2011050909).It was confirmed that all operations and inspections were executed as per applicable procedures.No deviations or non-conformances, which could have caused or contributed to the reported event were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was completed for the subject lot number (2011050909) and no other complaint was identified.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.

• Brand Name: OSSEOTITE IMPLANT 3.75 X 8.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10499152
• Report Number: 0001038806-2020-01328
• Device Sequence Number: 3123939
• Product Code: DZE
• UDI-Device Identifier: 00844868013167
• UDI-Public: (01)00844868013167(17)160530(10)2011050909(241)OSS385
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/30/2016
• Device Model Number: OSS385
• Device Catalogue Number: OSS385
• Device Lot Number: 2011050909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 09/07/2020
• Supplement Report FDA Received Date: 12/17/2020
• 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