MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,4.1MM,SBM,16; DENTAL IMPLANT

Catalog Number	TSV4B16
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/17/2021
Type of Reportable Event	Serious Injury
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.H3 other text : summary investigation.
Event or Problem Description
It was reported that the implant at tooth location #13 was removed due to infection.
Additional Manufacturer Narrative
This report is being submitted to relay corrected data and additional information.Based on the manufacturing date of the reported implant, the lot number of the implant has been updated to unknown.Implant date is older than the reported lot number's manufacturing date.The following sections are being reported: b4: date of this report was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H6: type of investigation code was added: 4110.H10: narrative/data was updated.The reported device was returned.Device malfunction has not occurred.Dhr review could not be performed since the lot number associated to the item was not provided.However, zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.A complaint history review by item number was conducted for the tsv4b16 dating back to 12 months.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported product for similar events (complaint category keyword: 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.Monthly trending to date has not identified any statistical triggers suggesting potential design or manufacturing related issues.Previously completed investigations for the infection of an implant have not identified any signals indicating potential non-conformances impacting the manufacturing and sterilization processes.Therefore, escalation to capa is not required.
Event or Problem Description
Additional information regarding the implant placement and removal dates was requested, however to date, no information has been received.

• Brand Name: IMP,TSV,4.1MM,SBM,16
• 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 ; 5619713230
• MDR Report Key: 17378988
• Report Number: 0002023141-2023-01993
• Device Sequence Number: 20408768
• Product Code: DZE
• UDI-Device Identifier: 00889024019256
• UDI-Public: (01)00889024019256(17)270503(10)1254255
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K072589
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2023

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: Health Professional
• Device Catalogue Number: TSV4B16
• Device Lot Number: 1254255
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2022
• 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: 47 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic