MAUDE Adverse Event Report: ZIMMER DENTAL IMP TM 4.1MM MTX FULL, 11.5MM; DENTAL IMPLANT

Model Number	TMT4B11
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	08/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Patient weight is not provided / unknown.Additional 510(k) numbers are k113753 and k112160.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
It is reported that primary stability was not achieved with implant in tooth site # 7 (universal).Site was grafted with allograft prior to implant placement.
Additional Manufacturer Narrative
This report is being submitted to relay additional information.Upon follow up with customer it was confirmed that the event no longer meets reportability requirements.No further medwatch reports will be submitted for this event." the following sections are being reported: b5: describe event or problem is updated h2: type of follow up was updated.H10: narrative/data was updated.
Event or Problem Description
Upon follow up with customer, it was confirmed that there was no stability at placement due to patient had insufficient bone.

• Brand Name: IMP TM 4.1MM MTX FULL, 11.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 12387613
• Report Number: 0002023141-2021-02355
• Device Sequence Number: 3602440
• Product Code: DZE
• UDI-Device Identifier: 00889024018945
• UDI-Public: (01)00889024018945(17)251005(10)1240266
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• 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: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2021

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: 10/05/2025
• Device Model Number: TMT4B11
• Device Catalogue Number: TMT4B11
• Device Lot Number: 1240266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 08/31/2021
• 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: 49 YR