MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,6.0,13,MTX,MG; DENTAL IMPLANT

Model Number	TSVT6B13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It is reported that patient returns approximately one month after removal of tooth #14(universal) and placement of implant.Patient states things seem to be healing more slowly than what he has experienced with prior implants.Upon examination, implant is stable, mild soft tissue setting against the buccal surface on the implant with a small crevice having formed between the buccal gingival margin in the healing cap.No visible debris.Healing cap removed and the site irrigated with peridex.A cover screw was placed and gelfoam tucked into the gingival defect.No signs of infection.Patient returned approximately after two weeks and soft tissue defect persist, subtle exposure of some of the crestal portion of the implant shoulder.The implant was removed.
Additional Manufacturer Narrative
Zimvie complaint (b)(4).Patient weight is not provided / unknown.Additional 510(k) number is k101880.
Event or Problem Description
No additional or corrected information to report.
Additional Manufacturer Narrative
This report is being submitted to report additional information.The product was returned.The reported event could not be verified through the provided x-ray.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 trends or corrective actions for the reported event 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 product was within specifications and conforming when it left zimvie.Dhr review for the lot had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.Sterilization record was reviewed and verified to have passed all sterilization activities with no issues or nonconformities identified.Complaint history review was performed for the reported lot number for similar events and no other complaint was identified.Functional testing could not be performed for the reported event.Therefore, the reported event could not be recreated.A definitive root cause could not be determined.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.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimvie will continue to monitor for trends.

• Brand Name: IMP,TSV,6.0,13,MTX,MG
• 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: 15274966
• Report Number: 0002023141-2022-02161
• Device Sequence Number: 6237200
• Product Code: DZE
• UDI-Device Identifier: 00889024019898
• UDI-Public: (01)00889024019898(17)241028(10)1233193
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K101977
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2022

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: 10/28/2024
• Device Model Number: TSVT6B13
• Device Catalogue Number: TSVT6B13
• Device Lot Number: 1233193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2022
• 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: 08/09/2022
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 08/23/2022
• Supplement Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2019
• 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 Age: 76 YR
• Patient Sex: Male