BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,MCOL MG,4.7MM,10M

    MDR report key: 24802115 · Received April 7, 2026

    Report

    Report Number
    0001038806-2026-01843
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    February 5, 2026
    Report Date
    April 7, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024019775
    PMA / PMN Number
    K111889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN PLACING THE IMPLANT WOULD GO ALL THE WAY INTO THE OSTEOTOMY. USED THE TAPS FROM THE REGULAR ZIMMER KIT AND STILL THE IMPLANT WOULD NOT GO TO DEPTH. FOR #29 DECIDED TO REMOVE THE 10MM AND REPLACE WITH AN 8MM IMPLANT. THE 10MM IMPLANT WOULD NOT REVERSE TORQUE AND WAS STUCK HALFWAY IN. THE CONNECTION APPEARED TO BE AFFECTED. USED THE REMOVAL IMPLANT TOOL AND WOULD NOT REVERSE TORQUE AND WAS LEFT STUCK IN THE IMPLANT. FINALLY USED A BUR TO REMOVE IMPLANT STRUCTURE AND EXTRACT THE IMPLANT. PLACED AN 8MM IMPLANT INTO THE #29 SOCKET. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION & EDEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442821 IMP,TSV,MCOL MG,4.7MM,10M DENTAL IMPLANT DZE ZIMVIE US CORP LLC 1297163 00889024019775

    Patients

    Seq Age Sex Outcome Treatment
    1