MAUDE Adverse Event Report: ZIMMER DENTAL IMP TM 4.7MM MTX FULL, 10; DENTAL IMPLANT

Model Number	TMTWB10
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Weight unknown / not provided.Pma/510(k) number k113753 and k112160.
Event or Problem Description
It was reported that mount did not disengage from the implant.The procedure was finished using another implant.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The following sections have been updated: b4: date of this report b5: describe event or problem d9: device available for evaluation change ¿no' to 'yes' g3: date received by the manufacturer h1: type of report, follow-up number h2: follow up type h3: device evaluated by manufacturer: change ¿no' to 'yes' h6: evaluation codes h10: additional narrative one implant was returned for investigation (image attached in complaint).Visual evaluation of the as returned product identified the implant/mount and the screw was disengaged.No apparent malfunction identified when functionally tested.Signs of use.A pre-existing condition noted on the per was unknown bone density type.The reported device was located on an unknown tooth site (fdi) and was placed and removed on the same day.The customer did not provide any pictures or x-rays.Review of appropriate documentation: documents reviewed: instructions for use - tapered screw-vent and trabecular metal implants, ifu4869 rev 9-10/19.Instructions for use ¿ prosthetics for zimmer dental implant systems ¿ ifu4894 rev 6 ¿ 08/19.Information identified: warnings (page 1).Per the applicable ifu, improper techniques may cause component failure.Dhr review: dhr review was completed for the subject lot number (1238357).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: complaint history review was performed for the reported lot number (1238357) for similar events and no other complaint was identified.Review completed utilizing keywords: 'does not disengage/release' post market trending review: april post market trending was reviewed and there were no actionable events or corrective actions for the reported event (does not disengage/release) or product (tmtwb10).No actionable items have been triggered that will affect complaint handling on our end for this month.Therefore, based on the available information and functional testing, device malfunction did not occur and the reported event was unconfirmed.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: IMP TM 4.7MM MTX FULL, 10
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 13234433
• Report Number: 0002023141-2022-00062
• Device Sequence Number: 19935748
• Product Code: DZE
• UDI-Device Identifier: 00889024019034
• UDI-Public: (01)00889024019034(17)250721(10)1238357
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K132258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/21/2025
• Device Model Number: TMTWB10
• Device Catalogue Number: TMTWB10
• Device Lot Number: 1238357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female