MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TM 3.7MM MTX,10MM; DENTAL IMPLAT

Model Number	TMMB10
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	09/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).
Event or Problem Description
It was reported the implant fractured and was removed.Inflammation and pain were reported as a result of the event.Patient would have to return to place a new implant.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number: (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.G3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H6: adverse event problem.H10: additional narrative.An imp, tm 3.7mm mtx, 10mm (tmmb10) was returned for investigation.Visual inspection of the as returned product identified worn marking due to usage and a fracture at the middle threads.Device history record (dhr) review was completed for the subject lot number (1230093).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: (1230093) for similar event and no other complaint was identified.Based on the available information, device malfunction did occur and the reported event was confirmed.

• Brand Name: IMP,TM 3.7MM MTX,10MM
• Common Device Name: DENTAL IMPLAT
• 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: 12881666
• Report Number: 0002023141-2021-03410
• Device Sequence Number: 5095305
• Product Code: DZE
• UDI-Device Identifier: 00889024018860
• UDI-Public: (01)00889024018860(17)240707(10)1230093
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/07/2024
• Device Model Number: TMMB10
• Device Catalogue Number: TMMB10
• Device Lot Number: 1230093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• 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: 11/05/2021
• Supplement Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 11/29/2021
• Supplement Report FDA Received Date: 05/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2019
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 85 KG