MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,4.7,16,MTX,MG; DENTAL IMPLANT

Model Number	TSVTWB16
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Weight unknown / not provided.Additional pma/510(k) number ¿ k101880.Fax number unknown / not provided.
Event or Problem Description
It was reported that the implant at tooth site #13 had fractured and was later removed.
Additional Manufacturer Narrative
This report is being submitted to relay corrected data and additional information.Associated lot #61669873 was manufactured prior to 24-sep-2015, as a result, a udi number is not required.
Event or Problem Description
No additional event information at the time of this report.
Event or Problem Description
No additional event information at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to relay device evaluation results and additional information.The following sections are being reported: b4: date of this report was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: component code was added: 4755.H6: investigation type codes were added: 4109, 4111 and 3331.H6: investigation findings code was added: 3252.H6: investigation conclusions codes were added: 4307.H10: narrative/data was updated.The product was returned and the reported event was confirmed following visual evaluation.Based on the evaluation, device malfunction has occurred.However, 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 event.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 they left zimmer biomet.Dhr review for the lot (61669873) had revealed no deviations nor non-conformances which could have caused or contributed the reported event.Complaint history review was performed for the reported lot (61669873) and no similar event or complaint was found.Functional testing could not be performed since the product was fractured.Therefore, the reported event could not be recreated.Based on the investigation, risk review and ifu, the most likely causes determined from the investigation are long term parafunctional habits of the patients (e.G.Clenching, bruxism and overloading) over the course of 10 years.No further investigation or immediate capa / hhe/d 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,TSV,4.7,16,MTX,MG
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11180578
• Report Number: 0002023141-2021-00107
• Device Sequence Number: 2994455
• Product Code: DZE
• UDI-Device Identifier: 00889024020023
• UDI-Public: (01)00889024020023(17)151130(10)61669873(241)TSVTWB16
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K101977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2021

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: 11/30/2015
• Device Model Number: TSVTWB16
• Device Catalogue Number: TSVTWB16
• Device Lot Number: 61669873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 04/22/2021; 04/26/2021
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 04/23/2021; 04/29/2021
• 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
• Patient Age: 57 YR