MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TAPERED SCR-V HA 6MM 5.7MM 11.5MM; DENTAL IMPLANT

Model Number	TSV6H11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported chronic pain since placement, tooth 30.Symptoms as a result of the event: pain.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.E1: last name unknown / not provided.G4: k013227.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One tapered screw-vent implant, ((b)(6)), unknown associated abutment and screw were returned for investigation.Visual/physical evaluation of the as returned product identified screw fragment inside the abutment and implant.The implant platform was damaged/fractured.Follow up attempts were made, however, the customer stated that there were no notifications of fractured screw or implant from the dr¿s notes ¿ the implant was returned due to biological failure and pain.It has been concluded that screw/implant fracture/damage might have occurred during implant removal procedures.Zimvie is not responsible for damages sustained during removal of devices and such damages are not considered as malfunctions.Dhr review was completed for the subject lot number 63613902.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 63613902 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿pain¿.The customer did not submit images for the reported event.Review of appropriate documentation: documents reviewed: instructions for use ¿ tapered screw-vent® and trabecular metal¿ implants, ifu4869 rev 9 - 10/19.Information identified: warnings.Per the applicable ifu, ¿improper technique can cause bone loss, patient injury, pain and implant failure¿.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was customer error ¿ improper techniques used during placement or patient factors.Therefore, based on the available information, device malfunction did not occur, and the reported event could not be verified as the exact details of event were unknown/unverifiable.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.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.

• Brand Name: IMPL TAPERED SCR-V HA 6MM 5.7MM 11.5MM
• 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: 16918901
• Report Number: 0002023141-2023-01322
• Device Sequence Number: 6921505
• Product Code: DZE
• UDI-Device Identifier: 00889024019461
• UDI-Public: (01)00889024019461(17)220430(10)63613902
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K061410
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2023

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: Other
• Device Expiration Date: 04/30/2022
• Device Model Number: TSV6H11
• Device Catalogue Number: TSV6H11
• Device Lot Number: 63613902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2017
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic