BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TWIST MP-1 3.75 MM 8 MM

    MDR report key: 25035500 · Received April 29, 2026

    Report

    Report Number
    0001038806-2026-02382
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    April 14, 2026
    Report Date
    April 29, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024013117
    PMA / PMN Number
    K013494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A2: AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED A3: GENDER UNKNOWN / NOT PROVIDED A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED D6A: IMPLANT DATE UNKNOWN / NOT PROVIDED D6B: EXPLANT DATE UNKNOWN / NOT PROVIDED G4: ADDITIONAL PMA/510(K) NUMBER K943604.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MOUNT IS STUCK AND WON'T COME OFF. DURING IMPLANTATION, THE DENTIST WAS UNABLE TO USE THE PRODUCT BECAUSE THE MOUNTING SCREW WOULD NOT COME LOOSE. REQUEST FOR IMPROVEMENT. HE RESOLVED THE ISSUE BY USING A REPLACEMENT PRODUCT WITH THE SAME PART NUMBER. TOOTH SITE # 6. COMPLETED WITH A REPLACEMENT OF THE SAME PRODUCT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508058 IMPL TWIST MP-1 3.75 MM 8 MM DENTAL IMPLANT DZE ZIMVIE US CORP LLC 2023051034 00889024013117

    Patients

    Seq Age Sex Outcome Treatment
    1