MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TWIST MP-1 3.75 MM 8 MM; DENTAL IMPLANT

Catalog Number	1988
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).G4: additional pma/510(k) number ¿ k943604.A summary investigation has been completed for infection events identifying that a definitive root cause cannot be identified due to the wide range of external (non-design/ non-manufacturing related) factors potentially impacting the sterility of the implant and its environment.Should additional information be received which indicates that the device may have caused or contributed to the infection event, an additional report will be submitted.
Event or Problem Description
It was reported that the patient experienced infection at implant tooth site #22, with associated pain.Therefore, the implant was removed.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).A summary investigation has been completed for infection events identifying that a definitive root cause cannot be identified due to the wide range of external (non-design/ non-manufacturing related) factors potentially impacting the sterility of the implant and its environment.Should additional information be received which indicates that the device may have caused or contributed to the infection event, an additional report will be submitted.Dhr review was completed for the subject lot number 2021010815.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Sterilization recordwas reviewed and verified to have passed all sterilization activities with no issues or nonconformities identified.Complaint history review was performed for the reported lot number 2021010815 for similar events and one other complaint was identified (b)(4).Review completed utilizing keywords: infection.As documented in the summary investigation, contributing factors for the reported event likely exist outside of zimvie control, including those related to patient biological factors/condition and surgical technique.Based on the summary investigation, no malfunction occurred upon investigation.The reported event remains non-verifiable as it is a medical condition.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: IMPL TWIST MP-1 3.75 MM 8 MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18244908
• Report Number: 0002023141-2023-03447
• Device Sequence Number: 15096047
• Product Code: DZE
• UDI-Device Identifier: 00889024013117
• UDI-Public: (01)00889024013117(17)260603(10)2021010815
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K013494
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2024

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: 06/02/2026
• Device Catalogue Number: 1988
• Device Lot Number: 2021010815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2021
• 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 Age: 58 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic