MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TM 3.7MM MTX FULL,13M; DENTAL IMPLANT

Model Number	TMTB13
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	05/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).A summary investigation has been completed for lack of primary stability events that do not allege a deficiency with the implant and identified that the reported event is likely due to biological factors which have an adverse effect on implant stability or is related to surgical technique and insertion torque.Due to a wide range of external (non-design/ non-manufacturing related), identifying a definitive root cause is generally not possible.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.
Event or Problem Description
Doctor indicated lack of primary stability, tooth site # 11 (universal).
Event or Problem Description
No additional or corrected information to report.
Additional Manufacturer Narrative
This report is being submitted to relay additional information.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 the 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.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: IMP,TM 3.7MM MTX FULL,13M
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 12100842
• Report Number: 0002023141-2021-01674
• Device Sequence Number: 14407987
• Product Code: DZE
• UDI-Device Identifier: 00889024019010
• UDI-Public: (01)00889024019010(17)250615(10)1236877
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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: 06/15/2025
• Device Model Number: TMTB13
• Device Catalogue Number: TMTB13
• Device Lot Number: 1236877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR