MAUDE Adverse Event Report: ZIMMER DENTAL IMP TM 4.1MM MTX FULL,13M; DENTAL IMPLANT

Model Number	TMT4B13
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported that the implant fractured.The patient reported pain and wants the implant removed and replaced.Tooth location unknown.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Additional pma/510(k) number ¿ k113753|k112160.Customer has indicated that the product will be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: h6: investigation type codes were added: 3331, 4109, 4110, 4111 and 4114.H6: investigation findings code was added: 3252.H6: investigation conclusions codes were added: 4307.One (1) imp tm 4.1mm mtx full,13m (tmt4b13) was not returned for investigation.Visual inspection could not be performed.However, evidence of malfunction that correlates with the complaint description was confirmed via x-ray.Based on the evaluation, device malfunction has occurred.However, there is no existing nonconformance / capa / hhe/d / ie / product hold against the reported device that did or could cause or contribute to the reported event.Monthly post market trending review identified no adverse trends or actionable trends for the reported event or device.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.Therefore, based on the available information, the product was within specifications and conforming when it left zimvie.Dhr review was completed for the subject lot number (1226159).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 (1226159) for similar events and no other complaint was identified.Functional testing could not be performed due to the nature of the device and event.Therefore, the reported event could not be recreated.A definitive root cause could not be determined.However, based on the investigation, risk review and ifu, the most likely causes determined from the investigation are inadequate treatment planning, clinician selects implant that is unable to resist long-term occlusal loading, clinician places implant in a patient with patient factors (e.G., bruxism) incompatible with long-term osseointegration of implant.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.
Event or Problem Description
No additional event information received at the time of this report.

• Brand Name: IMP TM 4.1MM MTX FULL,13M
• 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: 16334777
• Report Number: 0002023141-2023-00484
• Device Sequence Number: 6419665
• Product Code: DZE
• UDI-Device Identifier: 00889024018952
• UDI-Public: (01)00889024018952(17)240410(10)1226159
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K132258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2023

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: 04/10/2024
• Device Model Number: TMT4B13
• Device Catalogue Number: TMT4B13
• Device Lot Number: 1226159
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2019
• 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: Unknown