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

Model Number	TMMWB13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient weight unknown / not provided.Pma/510k: k113753, k112160.
Event or Problem Description
It was reported that the patient was having issues with nerve pain.The implant was solid but the patient wanted it removed.Tooth location # 18.
Additional Manufacturer Narrative
One imp tm 4.7mm mtx, 13mm ((b)(6)) was returned for investigation with an associated teha4567.As the alleged event occurred at the tissue level, the healing abutment will not be included as part of this investigation.Visual inspection of the as returned product identified signs of tissue attachment, and damage about the collar, which could be attributed to the removal process.The device was identified to be within design specification.No pre-existing conditions were noted on the per.The reported product was located on tooth # 18 (universal) and used for approximately 5 months.The reported event could not be recreated due to the nature of the dental device and event (medical conditions).The customer has not provided additional pictures or x-ray images of the product.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number 1230417.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 (1230417) for similar event and no other complaint was identified.Based on the available information, device malfunction has occurred, as the implant is noted to be damaged.However the reported event was non-verifiable.The following sections have been updated: b4: date of this report g3: date received by manufacturer g6: checked "follow-up" h2: checked follow-up type h3: changed "no" to "yes" h6: entered evaluation codes h10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.

• 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
• MDR Report Key: 12100910
• Report Number: 0002023141-2021-01675
• Device Sequence Number: 3820044
• Product Code: DZE
• UDI-Device Identifier: 00889024018921
• UDI-Public: (01)00889024018921(17)240716(10)1230417
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K132258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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
• Report Date (Section B): 11/04/2021

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: Lay User/Patient
• Device Expiration Date: 07/16/2024
• Device Model Number: TMMWB13
• Device Catalogue Number: TMMWB13
• Device Lot Number: 1230417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 11/04/2021
• 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