MAUDE Adverse Event Report: ZIMMER DENTAL IMP TM 6.0MM MTX FULL, 10; DENTAL IMPLANT

Model Number	TMT6B10
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient identifier unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.Date of event unknown / not provided.Fax number unknown / not provided.Additional pma/510(k) number ¿ k113753|k112160.Device remains implanted.
Event or Problem Description
It was reported that some of the threads are stripped on the inside of the implant on tooth site #19.
Event or Problem Description
No additional event information at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to relay additional information.The following sections are being reported: h6: component code was added: 4755.H6: tyoe of investigation codes were added: 4109, 4114 and 3331.H6: investigation findings code was added: 3221.H6: investigation conclusions code was added: 4310.The product was not returned.Therefore, the reported event could not be verified.Based on the evaluation, device malfunction could not be verified.Additionally, there is no existing nonconformance / capa / hhe/d / ie / product hold against the reported devices that did or could cause or contribute to the reported events.Monthly post market trending review identified no adverse trends or actionable trends for the reported event or device.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products.Therefore, based on the available information, the product was within specifications and conforming when it left zimmer biomet.Dhr review for the lot (1221504) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.Complaint history review was performed for the reported lot (1221504) and no similar event or complaint was found.Functional testing could not be performed since the product was not returned.Therefore, the reported event could not be recreated.Based on the investigation, risk review and ifu, the most likely cause determined from the investigation is excessive loading on abutment and implant assembly.No further investigation or immediate escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.

• Brand Name: IMP TM 6.0MM MTX FULL, 10
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11100239
• Report Number: 0002023141-2020-02439
• Device Sequence Number: 3781132
• Product Code: DZE
• UDI-Device Identifier: 00889024018969
• UDI-Public: (01)00889024018969(17)231029(10)1221504(241)TMT6B10
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2021

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: Lay User/Patient
• Device Expiration Date: 10/29/2023
• Device Model Number: TMT6B10
• Device Catalogue Number: TMT6B10
• Device Lot Number: 1221504
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 12/31/2020
• Supplement Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1