MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® TAPERED CERTAIN® PREVAIL® IMPLANT 6/5 X 8.5MM; DENTAL IMPLANT

Model Number	XIITP6585
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that the implant was removed due to pain that occurred after the patient stated she fell in (b)(6) 2022, broke her wrist and crowns on implants.Patient reports that since her fall, pain has become progressively worse and she was unable to bite down.Bridge mobile.
Additional Manufacturer Narrative
Multiple mdr reports were filed for this event.Please see associated report: 0001038806-2022-00726-1 and 0001038806-2022-01285-1.This report is being submitted to relay additional information and device evaluation.The following sections are being reported: h6: type of investigation codes were updated: 3331, 4109, 4110, 4111.H6: investigation findings code was updated: 213.H6: investigation conclusion code was updated: 67.Dhr review was completed for the subject lot numbers (2018011791, 2018110908).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance's, which could have caused or contributed to the reported event, were noted as part of the dhr.Lot numbers were inspected and passed all acceptance criteria by qa.Dhr review and complaint history review by lot number could not be performed, as the lot number associated with the reported product (unknown biomet screw) is not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.Sterilization records (op#0210) were reviewed and verified to have passed all sterilization activities with no issues or nonconformities identified.Complaint history review was performed for the reported lot numbers (2018011791, 2018110908) for similar events and no other complaint was identified.August post market trending was reviewed and there were no actionable events or corrective actions for the reported events (pain & fracture screw) or product (xiitp4311, xiitp6585, unknown biomet screw).No actionable items have been triggered that will affect complaint handling on our end for this month.Therefore, based on the available information, screw malfunction did occur, and the reported event fracture screw was confirmed.The reported event (pain) could not be verified as the exact details of event and patient anatomical conditions were unknown/non-verifiable.
Event or Problem Description
No additional event information was received at the time of this report.

• Brand Name: OSSEOTITE® TAPERED CERTAIN® PREVAIL® IMPLANT 6/5 X 8.5MM
• 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: 14414375
• Report Number: 0001038806-2022-00727
• Device Sequence Number: 14840631
• Product Code: DZE
• UDI-Device Identifier: 00844868022244
• UDI-Public: (01)00844868022244(17)231127(10)2018110908
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K130949
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 10/31/2022

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: Lay User/Patient
• Device Expiration Date: 11/27/2023
• Device Model Number: XIITP6585
• Device Catalogue Number: XIITP6585
• Device Lot Number: 2018110908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2022
• 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: 04/29/2022
• Supplement Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 05/17/2022
• Supplement Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2018
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female