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

Model Number	TMTWB13
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report was previously submitted under the incorrect mfr 0001038806 - 2019 - 00706 on 15-jul-2019.A reassessment has been completed.One imp tm 4.7 mm mtx full, 13 (tmtwb13) was returned for investigation.Visual inspection of the as returned products identified wear and debris within the drive feature of the implant and the trabecular metal features.No pre-existing conditions was noted on the per.The reported product was located on tooth number 14 and used for 20 days.The customer has not provided additional pictures or x-ray images of the product.Dhr review was completed for the subject lot number 1223137.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.Lot was inspected and passed all acceptance criteria by qa.Review of the raw materials report of the dhrs under op 10 revealed no non-conformance or rejections based on material specification.It is not indicated by the customer that the patient had sensitivity to any particular metal type, therefore material characterization was not reviewed.Complaint history review was performed for the reported lot number (1223137) for similar event and no other complaint was identified.July post market trending was reviewed and there were no negative trends or corrective actions for the reported event (allergic reaction) or products (tmtwb13).Therefore, based on the available information, device malfunction has not occurred and the reported event was non-verifiable.Zimmer biomet complaint (b)(4).Event date: not provided.Additional pma/510(k) number: k113753, k112160.
Event or Problem Description
It was reported that doctor suspected allergic reaction and implant (tmtwb13) was removed.Site was bone grafted.Tooth location 14.

• Brand Name: IMP TM 4.7MM MTX FULL, 13
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9257216
• Report Number: 0002023141-2019-00996
• Device Sequence Number: 19292858
• Product Code: DZE
• UDI-Device Identifier: 00889024019058
• UDI-Public: (01)00889024019058(17)240207(10)1223137(241)
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/07/2024
• Device Model Number: TMTWB13
• Device Catalogue Number: TMTWB13
• Device Lot Number: 1223137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 10/30/2019
• 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: 65 YR
• Patient Weight: 64