MAUDE Adverse Event Report: ZIMMER DENTAL IMP TM 3.7MM MTX FULL,11.5MM; DENTAL IMPLANT

Model Number	TMTB11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant was removed due to an infection at the site.Tooth #24.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
No additional event information was received at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.Dhr review was completed for the subject lot number 1235715.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.Sterilization record op# 170 - str2 was 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 1235715 for similar events and no other complaint was identified.As documented in the summary investigation, contributing factors for these reported events likely exist outside of zimmer biomet 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.
Additional Manufacturer Narrative
This report is being submitted to relay corrected data.Corrected data: section d9 device availability/product returned to manufacturer should not have been checked as reported on 0002023141-2022-01341.
Event or Problem Description
No additional event information was received at the time of this report.

• Brand Name: IMP TM 3.7MM MTX FULL,11.5MM
• 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 14569476
• Report Number: 0002023141-2022-01341
• Device Sequence Number: 20366191
• Product Code: DZE
• UDI-Device Identifier: 00889024019003
• UDI-Public: (01)00889024019003(17)250211(10)1235715
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K132258
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/16/2022

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: 02/11/2025
• Device Model Number: TMTB11
• Device Catalogue Number: TMTB11
• Device Lot Number: 1235715
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2022
• Supplement Date Received by Manufacturer: 10/31/2022; 11/15/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 11/04/2022; 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2020
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male