MAUDE Adverse Event Report: ZIMVIE US CORP LLC ABUT TAPERED ONE-PIECE SCR-V 3.5MM 3MM; DENTAL ABUTMENT

Catalog Number	TAC3
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A1: patient identifier: unknown / not provided.A4: patient weight: unknown / not provided.D10: concomitant medical product: tac3, abut tapered one-piece scr-v 3.5mm 3mm, lot: 2022051373.
Event or Problem Description
It was reported that the abutments spontaneously loosened despite tightening to 30 ncm with the torque wrench.Abutments placed on (b)(6) 2025 and removed on (b)(6) 2025.Procedure was completed with other abutments.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.G3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H6: adverse event problem.H11: additional narrative.Zimvie received one (1) (b)(6) (abut tapered one-piece scr-v 3.5mm 3mm) for evaluation.Visual evaluation was performed, the abutment shows signs of wear/use.Tested with in-house implant and it threads as intended.No allegations were made against returned healing cap.The healing cap was recorded in the concomitant medical product section.Dhr review was completed for the subject lot number 2120037117.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 2120037117 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental : functional : loosening¿ based on the investigation and risk management file review, the most likely root cause determined from the investigation was customer error or patient factors.Therefore, based on the available information, a device malfunction could not be verified.The abutment threaded into an in-house implant as intended.The reported loosening event was non-verifiable with all the available information.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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: ABUT TAPERED ONE-PIECE SCR-V 3.5MM 3MM
• Common Device Name: DENTAL ABUTMENT
• 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: 23920109
• Report Number: 0001038806-2025-04114
• Device Sequence Number: 8825120
• Product Code: DZE
• UDI-Device Identifier: 00889024018426
• UDI-Public: (01)00889024018426(17)300731(10)2120037117
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K011028
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2026

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: TAC3
• Device Lot Number: 2120037117
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2025
• 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: 72 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic