MAUDE Adverse Event Report: ZIMVIE US CORP LLC ABUT TAPERED 1-PC SCREW-VENT 3.5MM 1MM; DENTAL ABUTMENT

Catalog Number	TAC1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2025
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: tac1, abut tapered 1-pc screw-vent 3.5mm 1mm, lot: 63230377.
Event or Problem Description
It was reported, that two tac1 abutments from the same bridge (#24 - #25) were replaced due to being fractured: in one abutment, the screw fractured inside the implant (the fractured fragment was removed and the implant was not affected), and in the other, the platform base was fractured.Abutments were placed on (b)(6) 2018 and rempved on (b)(6) 2025.Bridge remained intact.The procedure was completed using two new tac1 abutments.This report refers to abutment fractured at the screw part.
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) tac1, (abut tapered 1-pc screw-vent 3.5mm 1mm) for evaluation.Visual evaluation was performed, a fracture has been identified at the threads.Dhr review was completed for the subject lot number 63230377.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 63230377 for similar events and one other (b)(4) was identified.Review completed utilizing keywords: dental : functional : fracture : screw based on the investigation and risk management file review, the most likely root cause determined from the investigation was torque applied during placement/ seating exceeds recommended value.Therefore, based on the available information, a device malfunction did occur.The fracture has been identified on the threads.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.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 1-PC SCREW-VENT 3.5MM 1MM
• 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: 24256518
• Report Number: 0001038806-2026-00549
• Device Sequence Number: 8355886
• Product Code: NHA
• UDI-Device Identifier: 00889024018402
• UDI-Public: (01)00889024018402(17)201130(10)63230377
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K060880
• 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): 03/16/2026

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 Expiration Date: 11/30/2020
• Device Catalogue Number: TAC1
• Device Lot Number: 63230377
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/16/2026
• Is the Reporter a Health Professional?: Yes
• 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: 02/04/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2015
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL ABUTMENT SEE H10 NARRATIVE.
• Patient Age: 57 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic