MAUDE Adverse Event Report: ZIMMER DENTAL IMP, TSV, 4.1, 10, MTXF, MG,HA; DENTAL IMPLANT

Model Number	TSVT4H10
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the abutment portion was stuck to implant, unable to remove / detach.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Zimvie received one (1) tsvt4h10, (imp, tsv, 4.1, 10, mtxf, mg,ha) for evaluation (images are attached).Visual evaluation / functional test was performed, and cover screw would not detach as intended.Dhr review was completed for the subject lot number 1256694.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 1256694 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : functional : does not disengage/release.The customer did not submit images for the reported event.Based on the investigation and risk management file review as per (b)(4), the most likely root cause determined from the investigation were missing or confusing instructions for use and excessive torque used to place restorative component or debris stuck in implant.Therefore, based on the available information, a device malfunction did occur.The cover screw would not detach as intended.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.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.The following sections have been updated: g6: checked "follow-up." h3: changed "no" to "yes.".
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: IMP, TSV, 4.1, 10, MTXF, MG,HA
• 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: 16944690
• Report Number: 0002023141-2023-01365
• Device Sequence Number: 17736359
• Product Code: DZE
• UDI-Device Identifier: 00889024344198
• UDI-Public: (01)00889024344198(17)271202(10)1256694
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133339
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/18/2023

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 Model Number: TSVT4H10
• Device Catalogue Number: TSVT4H10
• Device Lot Number: 1256694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2023
• 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: 04/26/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2022
• 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 Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic