MAUDE Adverse Event Report: ZIMMER DENTAL IMP TM 4.7MM MTX, 13MM; DENTAL IMPLANT

Model Number	TMMWB13
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Additional 510(k) numbers are k113753 and k112160.
Event or Problem Description
It was reported that the abutment and impression post were unable to seat in the implant.Further investigation found the implant to be fractured requiring removal.Tooth #30.
Event or Problem Description
It was reported that the abutment and impression post were unable to seat in the implant.Further investigation by the doctor found that the internal components of the implant were fractured and the internal hex had been stripped.
Additional Manufacturer Narrative
Supplemental medwatch provided as additional information was received by the customer.Please see the sections updated below.
Event or Problem Description
There is no update to the complaint description provided previously.
Additional Manufacturer Narrative
A imp tm 4.7mm mtx, 13mm (tmmwb13) was returned for investigation.Visual inspection of the as returned product identified worn markings due to usage and a fracture abutment hex inside and a fracture on the collar.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.No pre-existing conditions were noted on the per.The reported device was located on tooth # 30 and was used for approximately 3 years.Pictures or x-ray images were not provided.Review of appropriate documentation: documents reviewed: instructions for use for tapered screw-vent®, advent® and trabecular metal¿ implants 4869 rev 9 ¿ 10/19 information identified: contraindications, warnings, precautions, breakage, general considerations and adverse effects documents reviewed: instructions for use- prosthetics for zimmer dental implant systems (ifu 4894 rev 6 - 08/19) information identified: warnings, precautions, contraindications dhr review: dhr review was completed for the subject lot number (63363007).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: complaint history review was performed for the reported lot number (63363007) for similar event and no other complaint was identified.Review completed utilizing keywords: fracture implant post market trend review: march 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 did occur for the implant fracture was confirmed.

• Brand Name: IMP TM 4.7MM MTX, 13MM
• 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: 12838235
• Report Number: 0002023141-2021-03335
• Device Sequence Number: 17216491
• Product Code: DZE
• UDI-Device Identifier: 00889024018921
• UDI-Public: (01)00889024018921(17)210531(10)63363007
• 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: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/13/2022

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: Lay User/Patient
• Device Expiration Date: 05/31/2021
• Device Model Number: TMMWB13
• Device Catalogue Number: TMMWB13
• Device Lot Number: 63363007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• 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: 10/26/2021
• Supplement Date Received by Manufacturer: 11/16/2021; 05/12/2022
• Initial Report FDA Received Date: 11/18/2021
• Supplement Report FDA Received Date: 12/14/2021; 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2016
• 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: 60 YR
• Patient Sex: Male