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

Model Number	TMMB10
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the implant at tooth site #46 fractured during placement as was removed.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One imp,tm 3.7mm mtx,10mm (tmmb10) was returned for investigation (image 1-3).Visual inspection of the as returned product identified signs of wear from placement and debris in the trabecular metal.The device is fractured at the tm base.No pre-existing conditions were noted on the per.The reported product was located on tooth # 46 (fdi) and the fracture occurred the same day as placement.The reported event could not be recreated due to the nature of the dental device and event (fracture).Appropriate documentation was reviewed.Dhr review was completed for the subject lot number.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 for similar event and no other complaint was identified.Based on the available information, device malfunction has occurred and the reported event was confirmed.

• Brand Name: IMP,TM 3.7MM MTX,10MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9950130
• Report Number: 0002023141-2020-00754
• Device Sequence Number: 3354483
• Product Code: DZE
• UDI-Device Identifier: 00889024018860
• UDI-Public: (01)00889024018860(17)220131(10)63516188(241)TMMB10
• Combination Product (Y/N): N
• PMA/510(K) Number: K132258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2020

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: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: TMMB10
• Device Catalogue Number: TMMB10
• Device Lot Number: 63516188
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 06/08/2020
• 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: 60 YR
• Patient Weight: 85