MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® TAPERED CERTAIN® IMPLANT 5 X 13MM; DENTAL IMPLANT

Model Number	XIFNT513
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported inside stripped when torque.Per indicates implant placed and removed immediately during surgery.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Age and date of birth unknown / not provided.Gender unknown / not provided.Patient weight unknown / not provided.Date of event unknown / not provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
An osseotiteâ® tapered certainâ® implant 5 x 13mm (xifnt513) was returned for investigation.Visual inspection of the as returned product identified worn markings and damage drive feature and outside of implant.Implant appears stripped internally.Malfunction.No pre-existing conditions were noted on the per.The reported device location is unknown, and length of usage is the same day.Pictures or x-ray images were not provided.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number (2021051426).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 (2021051426) for similar event and no other complaint was identified.Sep post market trending was reviewed and there were no actionable events or corrective actions for the reported event or device.Based on the available information, device malfunction did occur, and the reported event was confirmed.

• Brand Name: OSSEOTITE® TAPERED CERTAIN® IMPLANT 5 X 13MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 14713720
• Report Number: 0001038806-2022-00931
• Device Sequence Number: 2175382
• Product Code: DZE
• UDI-Device Identifier: 00844868022022
• UDI-Public: (01)00844868022022(17)260614(10)2021051426
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K130949
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2022

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: 06/14/2026
• Device Model Number: XIFNT513
• Device Catalogue Number: XIFNT513
• Device Lot Number: 2021051426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2022
• Supplement Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose