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	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmerbiomet complaint number cmp (b)(4).Weight unknown / not provided.Additional pma/510(k) number ¿ k1.13753|k112160.Fax number unknown / not provided.
Event or Problem Description
It was reported that the patient came into the office with a loose implant bridge in hand and the implants at tooth sites #7 & 10 were fractured.Implants were removed.
Additional Manufacturer Narrative
This report is being submitted to relay device evaluation results and additional information.The following sections are being reported: b4: date of this report was updated.D9: device availability was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: component code was added: 4755.H6: investigation type codes were added: 4109 and 4111.H6: investigation findings code was added: 3252.H6: investigation conclusions codes were added: 4307.H10: narrative/data was updated.The product was returned and the reported event was confirmed following visual and pictorial evaluation.Based on the evaluation, device malfunction has occurred.However, there is no existing nonconformance / capa / hhe/d / ie / product hold against the reported devices 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.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products.Therefore, based on the available information, the product was within specifications and conforming when the unit left zimmer biomet.The dhr was not available electronically for the subject lot number (1226430).Therefore, it could not be further reviewed at the time of the investigation.A notification has been sent to manufacturing to request the dhr for review.The pce will be reopened and updated if there is any indication of nonconformance, or any possible manufacturing issue related to the reported event.Complaint history review was performed for the reported lot (1226430) for similar complaints/events and no other complaints were identified.Functional testing could not be performed since the device was fractured.Therefore, the reported event could not be recreated.Based on the investigation, risk review and ifu, the most likely causes determined from the investigation are improper techniques used during placement or use of implant outside of intended use.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 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
• MDR Report Key: 11603344
• Report Number: 0002023141-2021-00828
• Device Sequence Number: 4205831
• Product Code: DZE
• UDI-Device Identifier: 00889024018952
• UDI-Public: (01)00889024018952(17)240325(10)1226430
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K132258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/25/2024
• Device Model Number: TMT4B13
• Device Catalogue Number: TMT4B13
• Device Lot Number: 1226430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 05/13/2021
• 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: 61 YR