MAUDE Adverse Event Report: ZIMMER DENTAL IMP TM 3.7MM MTX,13MM; DENTAL IMPLANT

Model Number	TMMB13
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that the internal hex fractured resulting in failure of prosthesis and necessitating implant removal at tooth site # 5.Site grafted with barrier membrane.Patient to return for future implant replacement.As a result of this event, injury reported is due to implant removal/socket graft.Symptoms as a result of the event: none reported.
Additional Manufacturer Narrative
One trabecular metal implant (tmmb13) was returned for investigation.Visual evaluation of the as returned product identified a fractured hex and bone residue around the external threads due to usage functional testing could not be performed since the product was fractured/damaged.Pre-existing condition noted on the per was moderate bone density ¿ type ii.The reported device had been placed on tooth #5 (unknown notation system) for approximately 1 year.X-ray image was not provided.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number (63529074).It was confirmed that all operations and inspections were executed as per applicable procedures.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 completed for the subject lot number (63529074) and no other complaints about nonconforming products were identified.Based on the available information, device malfunction did occur and the reported event was confirmed.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: IMP TM 3.7MM MTX,13MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10279542
• Report Number: 0002023141-2020-01056
• Device Sequence Number: 11414043
• Product Code: DZE
• UDI-Device Identifier: 00889024018884
• UDI-Public: (01)00889024018884(17)211130(10)63529074(241)TMMB13
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K132258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2020

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: 11/30/2021
• Device Model Number: TMMB13
• Device Catalogue Number: TMMB13
• Device Lot Number: 63529074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 10/22/2020
• 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: 64 YR