MAUDE Adverse Event Report: ZIMMER DENTAL IMP TM 4.7MM MTX FULL, 11.5MM; DENTAL IMPLANT

Model Number	TMTWB11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Patient weight is not provided / unknown.Additional 510(k) numbers are k113753 and k112160.Device not returned to manufacturer.
Event or Problem Description
Doctor reported that when viewing the x-ray after 1 month of placement of implant tmtwb11, doctor decided to change the implant to a smaller length.Tooth site # 4.
Additional Manufacturer Narrative
This report is being submitted to relay additional information.The following sections are being reported: method code was updated to 3331 and 4109.Results code was updated to 213.Conclusions code was updated to 4310.The reported event is no confirmed with the information provided and after review of the returned product.Visual inspection of the as returned product identified wear and debris functional testing to recreate the reported event could not be performed due to the nature of the device and event.A device history record (dhr) review was completed for the reported device lot.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance, which could have caused or contributed to the reported event was noted as part of the dhr.A complaint history review was completed for the reported device lot for similar event and no other complaint was identified.A definitive root cause for the reported event could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional or corrected information to report.

• Brand Name: IMP TM 4.7MM MTX FULL, 11.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9156974
• Report Number: 0002023141-2019-00837
• Device Sequence Number: 11418834
• Product Code: DZE
• UDI-Device Identifier: 00889024019041
• UDI-Public: (01)00889024019041(17)231010(10)1219141(241)TMTWB11
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/10/2023
• Device Model Number: TMTWB11
• Device Catalogue Number: TMTWB11
• Device Lot Number: 1219141
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/06/2019
• Supplement Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 12/19/2019
• 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: 42 YR