MAUDE Adverse Event Report: ZIMMER DENTAL IMP TM 4.1MM MTX,10MM; DENTAL IMPLANT

Model Number	TMM4B10
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Osteolysis (2377)
Date of Event	05/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Weight unknown / not provided.Pma/510(k) number k113753 and k112160.
Event or Problem Description
It was reported that the implant has been fractured "in half" and also reports peri-implantitis.The doctor also confirms that the procedure was not completed with another implant on the same day and that the patient will have to return in the future to remove the broken implant.The doctor confirms that the patient did not suffer any negative impact on his health.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The following sections have been updated: h3: device evaluated by manufacturer: change ¿no' to 'yes'.An imp tm 4.1mm mtx,10mm was returned for investigation.Visual inspection of the as returned product identified slightly dried blood and a fracture at the threads.The reported device was location is 36 (fdi) and was used for approximately 7 years.Device history record (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.Post market trending was reviewed and there were no actionable events or corrective actions for the reported event or device.Based on the available information, device malfunction could not be verified and the reported event was non-verifiable for peri-implantits however did occur and the reported event was confirmed for fracture.
Event or Problem Description
The doctor reports that the implant has been fractured in half.The doctor also confirms that the procedure was not completed with another implant on the same day and that the patient would have to return in the future to remove the broken implant.The doctor confirms that the patient did not suffer any negative impact on his health.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4) the following sections have been updated: b4: date of this report b5: describe event or problem g3: date received by manufacturer h1: type of report, follow-up number h2: follow up type h6: evaluation codes 2377 - osteolysis and1930 - unspecified infection not applicable.H10: additional narrative.

• Brand Name: IMP TM 4.1MM MTX,10MM
• 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: 12452026
• Report Number: 0002023141-2021-02516
• Device Sequence Number: 13764288
• Product Code: DZE
• UDI-Device Identifier: 00889024018808
• UDI-Public: (01)00889024018808(17)220531(10)63663507
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K132258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2022

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: Lay User/Patient
• Device Expiration Date: 05/31/2022
• Device Model Number: TMM4B10
• Device Catalogue Number: TMM4B10
• Device Lot Number: 63663507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• 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: 08/19/2021
• Supplement Date Received by Manufacturer: 01/31/2022; 02/07/2022
• Initial Report FDA Received Date: 09/10/2021
• Supplement Report FDA Received Date: 02/03/2022; 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2017
• 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: 49 YR
• Patient Sex: Male