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

Model Number	TMM4B11
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Premarket identification k113753 and k112160.
Event or Problem Description
Doctor reported implant fracture with trauma at tooth site 46.Patient came on (b)(6) 2022 with fractured implant, the crown is at medical center.The remaining part of the implant remains in the jaw.Patient has been rescheduled for removal of the remaining part of the fractured implant.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following sections have been updated: b4: date of this report.B5: describe event or problem.D4: udi updated.G3: date received by the manufacturer h1: type of report, follow-up number h2: follow up type.H6: evaluation codes.H10: additional narrative.Udi updated.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).One implant was returned for investigation.Visual evaluation of the as returned implant identified that the implant fractured at the threads.Zimvie is not responsible for any damage caused by the clinician's removal of the device.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.Pre-existing condition noted on the per was high bone density (type i).The reported device was at tooth location 46 (fdi) for approximately 1 year, 4 months.The customer did not provide images or x-rays.Review of appropriate documents: instructions for use - tapered screw-vent and trabecular metal implants - ifu4869 rev 9 - 10/2019.Information identified: 'warnings' 'precautions' 'sterility' 'potential adverse events' dhr review was completed for the subject lot number (1237195).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.Complaint history review was performed for the reported lot number for similar events and no other complaint was identified.Review completed utilizing keywords: 'fracture implant'.January post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.No actionable items have been triggered that will affect complaint handling on our end for this month.Therefore, based on the available information, device malfunction did occur, and the reported event was confirmed.

• Brand Name: IMP TM 4.1MM MTX,11.5MM
• 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: 15980928
• Report Number: 0002023141-2022-03115
• Device Sequence Number: 5859064
• Product Code: DZE
• UDI-Device Identifier: 00889024018815
• UDI-Public: (01)00889024018815(17)250621(10)1237195
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K132258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/21/2025
• Device Model Number: TMM4B11
• Device Catalogue Number: TMM4B11
• Device Lot Number: 1237195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2022
• 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: 11/21/2022
• Supplement Date Received by Manufacturer: 03/23/2023; 03/21/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 03/30/2023; 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2020
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male