MAUDE Adverse Event Report: ZIMVIE US CORP LLC TSX IMPLANT, 3.7MMD, 13MML; DENTAL IMPLANT

Catalog Number	TSX37B13
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: weight unknown / not provided.D10: umua-tsv3525-17s, tapered screw-vent® universal multi-unit abutment; 3.5mm(d) x 2.5mm(h) x 17.° customer has indicated that the product is in process of being returned to zimvie for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the implant and abutment got stuck during placement and were unable to be disengaged.The procedure was completed with another implant.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.Correction: h1: type of reportable event was updated from serious injury to malfunction the following sections are being reported: b4: date of this report was updated.D9: device availability and return date were updated.G3: date received by manufacturer was updated.G6: type of report was updated.H1: type of reportable event was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: type of investigation codes were added: 4109, 4111 and 3331.H6: investigation findings code was added: 180.H6: investigation conclusions code was added: 4307.H11: narrative/data was updated.Zimvie received the reported implant for evaluation.Visual evaluation and a functional test were performed, the implant has signs of use.The abutments screws drive feature was worn.During a functional test, the abutment does not disengage/release from implant.Dhr review was completed for the subject lot number.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 for similar events and no other complaint was identified.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was customer error, applying to much torque/speed during seating.Therefore, based on the available information, device malfunction did occur.The abutment could not be removed from implant.The reported event was confirmed.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.
Event or Problem Description
No additional event information received at the time of this report.

• Brand Name: TSX IMPLANT, 3.7MMD, 13MML
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: mark mashburn ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 24434386
• Report Number: 0001038806-2026-00963
• Device Sequence Number: 10298237
• Product Code: DZE
• UDI-Device Identifier: 00844868045069
• UDI-Public: (01)00844868045069(17)301015(10)2120038227
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K220978
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: TSX37B13
• Device Lot Number: 2120038227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL ABUTMENT-SEE H10 NARRATIVE.
• Patient Age: 65 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic