BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABUT HEX-LOCK 3.5MM IMP 5 .5 FLARE

    MDR report key: 23725461 · Received December 5, 2025

    Report

    Report Number
    0001038806-2025-03592
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Date of Event
    August 29, 2025
    Report Date
    February 19, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024015180
    PMA / PMN Number
    K011028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    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.

    Description of Event or Problem · 0

    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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2857165 ABUT HEX-LOCK 3.5MM IMP 5 .5 FLARE DENTAL ABUTMENT DZE ZIMVIE US CORP LLC 2019011798 00889024015180

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female DENTAL IMPLANT SEE H10 NARRATIVE