MAUDE Adverse Event Report: OSSEOTITE® TAPERED CERTAIN® PREVAIL® IMPLANT 6/5 X 15MM; DENTAL IMPLANT

Model Number	XIITP6515
Medical Device Problem Code	Problem with Removal of Enzymatic Cleaner (1213)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).A summary investigation has been completed for lack of primary stability events that do not allege a deficiency with the implant and identified that the reported event is likely due to biological factors which have an adverse effect on implant stability or is related to surgical technique and insertion torque.Due to a wide range of external factors (non-design/ non-manufacturing related), identifying a definitive root cause is generally not possible.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.
Event or Problem Description
It was reported that primary stability could not be achieved with the implant.Tooth position # 15.

• Brand Name: OSSEOTITE® TAPERED CERTAIN® PREVAIL® IMPLANT 6/5 X 15MM
• Common Device Name: DENTAL IMPLANT
• MDR Report Key: 12725663
• Report Number: 0001038806-2021-02093
• Device Sequence Number: 11899580
• Product Code: DZE
• UDI-Device Identifier: 00844868022237
• UDI-Public: (01)00844868022237(17)250914(10)2020071270
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K130949
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/14/2025
• Device Model Number: XIITP6515
• Device Catalogue Number: XIITP6515
• Device Lot Number: 2020071270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 10/31/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2020
• 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 Age: 38 YR