MAUDE Adverse Event Report: ZIMMER DENTAL IMP TM 4.1MM MTX FULL,10M; DENTAL IMPLANT

Model Number	TMT4B10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	08/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported a sinus tract was noted on the buccal of this #13 implant.Doctor recommended removal and regrafting, let the area heal, then re-evaluate.Ibuprofen 800 mg #28 and amoxicillin 500mg #21 were prescribed.
Additional Manufacturer Narrative
Zimvie complaint (b)(4).Additional 510(k) numbers are k113753 and k112160.
Additional Manufacturer Narrative
This report is being submitted to report additional and corrected information to 0002023141 - 2023 - 00629.It was previously incorrectly reported that the product was returned to the manufacturer.The product was not returned to the manufacturer and that has now been corrected in this submission.The reported product was not returned for investigation.The reported event was non-verifiable with the information provided.Based on the evaluation, the device malfunction could not be verified.However, there is no existing nonconformance/capa/hhe/d/ie/product holds against the reported device that could cause or contribute to the reported event.Monthly post market trending review identified no actionable trends or corrective actions for the reported event or device.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.Therefore, based on the available information, the product was within specifications and likely conforming when it left zimvie.Dhr review was completed for the subject lot number.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, were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Sterilization record 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 for similar events and no other complaint was identified.A definitive root cause could not be identified.No further investigation and no immediate capa/hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimvie will continue to monitor for trends.
Event or Problem Description
No additional or corrected information to report.

• Brand Name: IMP TM 4.1MM MTX FULL,10M
• 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: 16426180
• Report Number: 0002023141-2023-00629
• Device Sequence Number: 5259549
• Product Code: DZE
• UDI-Device Identifier: 00889024018938
• UDI-Public: (01)00889024018938(17)251129(10)1241410
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2023

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: 11/29/2025
• Device Model Number: TMT4B10
• Device Catalogue Number: TMT4B10
• Device Lot Number: 1241410
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/07/2023
• 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: 02/07/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2020
• 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
• Patient Sex: Prefer Not To Disclose