MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,4.1,16,MTX,MG; DENTAL IMPLANT

Model Number	TSVT4B16
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Patient age is not provided / unknown.Initial reporter¿s title is not provided / unknown.
Event or Problem Description
It was reported that primary stability could not be reached with the implant in tooth site # 24.
Additional Manufacturer Narrative
This report is being submitted to report additional information.Similar complaints for the inability to achieve primary stability have been previously investigated.Visual and dimensional evaluations of the previously returned product have not identified or suggested manufacturing non-conformances.While non-conformances were identified for some lots during manufacturing records reviews, the documented disposition actions for each have not suggested the likely release of non-conforming product.To date, all complaint data was found to be conforming and did not meet capa/hhe/d/ie escalation.Therefore, there were no complaints which confirmed a manufacturing or design related issue caused or contributed to the reported event.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 was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number for similar event and no other complaint was identified.As documented in the summary investigation, contributing factors for this reported event likely exist outside of zimmer biomet control, including those related to patient biological factors/condition and surgical technique.Dental implants are designed and manufactured to achieve osseointegration after placement into the osteotomy using the recommended surgical protocol.The inability to achieve primary stability is a well-documented, previously investigated failure which is currently trended on a monthly basis.Current implant design and manufacturing risk documentation assess unable to place implant into osteotomy as potential failures, ultimately through osseointegration failure, with adequate controls in place.Monthly trending to date has not identified any statistical triggers suggesting potential design or manufacturing related issues.Previously completed investigations for the inability to place implants into osteotomy have not identified any signals indicating potential manufacturing non-conformances impacting primary stability.With no signals indicating a systemic quality issue, no escalation to capa is required.
Event or Problem Description
No additional or corrected information to report.

• Brand Name: IMP,TSV,4.1,16,MTX,MG
• 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: 12726888
• Report Number: 0002023141-2021-03079
• Device Sequence Number: 1467925
• Product Code: DZE
• UDI-Device Identifier: 00889024019850
• UDI-Public: (01)00889024019850(17)240514(10)1228587
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K101977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2022

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: Health Professional
• Device Expiration Date: 05/14/2024
• Device Model Number: TSVT4B16
• Device Catalogue Number: TSVT4B16
• Device Lot Number: 1228587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/12/2021
• Supplement Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 11/01/2021
• Supplement Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2019
• 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 Sex: Female
• Patient Weight: 71 KG