MAUDE Adverse Event Report: ZIMVIE US CORP LLC ABUT HEX-LOCK 3.5MM IMP 5 .5 FLARE; DENTAL ABUTMENT

Catalog Number	HLA3/5
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an implant at tooth site 46 was removed due to a fracture at the implant collar.Patient attended as an emergency due to loss of the crown on implant 46.Examination revealed a fractured portion of the implant collar emerging at the gingival level, with the abutment screw fractured inside the implant.The patient reported no pain.Procedure was not completed.This complaint refers to the screw abutment fracture.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).D10.Concomitant medical products tsvb11, impl tapered scr-v mtx 3.7mm 3.5mm 11.5mm lot 1214131.G4: premarket identification k013227/k953101.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Zimvie received one (1) hla3/5, (abut hex-lock 3.5mm imp 5.5 flare) for evaluation.Ups shipment has been lost in transit.A claim has been placed.If ups locates the shipment, the complaint will be re-opened and updated accordingly.Dhr review was completed for the subject lot number 2019011798.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 2019011798 for similar events and no other complaint 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 were torque applied during placement/ seating exceeds recommended value.Therefore, based on the available information, a device malfunction could not be verified.The reported event is non-verifiable.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 HEX-LOCK 3.5MM IMP 5 .5 FLARE
• 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: 23725461
• Report Number: 0001038806-2025-03592
• Device Sequence Number: 13434758
• Product Code: DZE
• UDI-Device Identifier: 00889024015180
• UDI-Public: (01)00889024015180(17)240129(10)2019011798
• 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): 02/19/2026

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: 01/29/2024
• Device Catalogue Number: HLA3/5
• Device Lot Number: 2019011798
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/25/2025
• 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: 12/05/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2019
• 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 IMPLANT SEE H10 NARRATIVE
• Patient Age: 61 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic