BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,4.7,10,MTX,MG

    MDR report key: 23597831 · Received November 19, 2025

    Report

    Report Number
    0001038806-2025-03283
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    October 29, 2025
    Report Date
    November 19, 2025
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024019997
    PMA / PMN Number
    K101977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). G4: ADDITIONAL PMA/510(K) NUMBER ¿ K101880. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED AS IT HAD DAMAGED THREADS. PATIENT PRESENTED ON (B)(6) WITH A LOOSE TIBASE SUPPORTED IMPLANT CROWN. THE SCREW COULD NOT BE TIGHTENED AND A HEALING ABUTMENT COULD NOT BE PLACED. THE CUSTOMER FELT THAT THE INTERNAL THREADS WERE STRIPPED. THE THREADS WERE TAPPED AND THE CROWN WAS DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2490871 IMP,TSV,4.7,10,MTX,MG DENTAL IMPLANT DZE ZIMVIE US CORP LLC 1270099 00889024019997

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male