MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,MCOL MG,6.0MM,8MM,MTX; DENTAL IMPLANT

Model Number	TSVM6B8
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Sinus Perforation (2277)
Date of Event	08/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Age and date of birth unknown / not provided.Weight unknown / not provided.Pma/510(k) number: k101880.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that implant on tooth site #14 was removed due to sinus perforation.Symptoms of the event: sinusitis, inflammation and pain.
Event or Problem Description
No additional event information was received at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.One (1) imp,tsv,mcol mg,6.0mm,8mm,mtx (tsvm6b8) was returned for investigation.Visual evaluation of the as returned product identified the implant had bone debris on external threads.External platform and micro thread damage possibly due to the removal process.Measurement¿s match drawing, they were measured by using caliper.No malfunction was identified during analysis.Based on the evaluation, device malfunction has not occurred.Additionally, there is no existing nonconformance / capa / hhe/d / ie / product hold against the reported device that did or could cause or contribute to the reported event.Monthly post market trending review identified no actionable events or corrective actions for the reported events or device.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming products.Therefore, based on the available information, the device was within specifications and conforming when it left zimvie.Dhr review was completed for the subject lot number 1243902.It was confirmed that all operations and inspections were executed as per applicable procedure.Complaint history review was performed for the reported lot number 1243902 for similar events and no other complaint was identified.The implant could not be functionally tested for the reported event (perforated sinus).Therefore, the reported event could not be recreated.The complaint is not related to the functional performance of the device.A definitive root cause could not be determined.However, based on the investigation, risk review and ifu, the most likely causes determined from the investigation is an implant of an inappropriate size or improper techniques can cause bone loss, patient injury, pain and implant failure.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was 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,MCOL MG,6.0MM,8MM,MTX
• 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: 15431022
• Report Number: 0002023141-2022-02399
• Device Sequence Number: 18069690
• Product Code: DZE
• UDI-Device Identifier: 00889024019713
• UDI-Public: (01)00889024019713(17)260406(10)1243902
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K111889
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2023

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: 04/06/2026
• Device Model Number: TSVM6B8
• Device Catalogue Number: TSVM6B8
• Device Lot Number: 1243902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2022
• 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: 08/30/2022
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 02/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2021
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female