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

Model Number	TMMB13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Increased Sensitivity (2065)
Date of Event	01/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Weight unknown / not provided.
Event or Problem Description
It was reported hyperesthesia.The implant tmmb13 in dental site 11 was removed.Delay in the procedure was reported.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One imp tm 3.7mm mtx,13mm (tmmb13) has been returned for investigation.Visual evaluation of the as returned product identified minor signs of use and no apparent malfunction.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.No pre-existing conditions were noted on the per, the patient had unknown bone density.The reported device was located on tooth # 23 (fdi) and was implanted and removed on the same day.The customer did not provide pictures or x-rays.Device history record (dhr) review was completed for the subject lot number (1219714).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, were 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 (1219714) for similar event and no other complaint was identified.Therefore, based on the available information, device malfunction did not occur and the reported event was non-verifiable.A definitive root cause could not be identified.

• 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: 9841110
• Report Number: 0002023141-2020-00559
• Device Sequence Number: 764465
• Product Code: DZE
• UDI-Device Identifier: 00889024018884
• UDI-Public: (01)00889024018884(17)230912(10)1219714(241)TMMB13
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K132258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/12/2023
• Device Model Number: TMMB13
• Device Catalogue Number: TMMB13
• Device Lot Number: 1219714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 05/01/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 05/13/2020
• 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: 56 YR