BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V SBM 6M M 5.7MM 13MM

    MDR report key: 24608222 · Received March 16, 2026

    Report

    Report Number
    0001038806-2026-01420
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Report Date
    April 24, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A1: PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. A2: AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. A3: GENDER UNKNOWN / NOT PROVIDED. A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. B3: DATE OF EVENT UNKNOWN / NOT PROVIDED. E1: EMAIL UNKNOWN / NOT PROVIDED. E1: LAST NAME UNKNOWN / NOT PROVIDED. G4: ADDITIONAL PMA/510(K) NUMBER: K011028, K013227.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT CAME IN FOR FOLLOW UP AND CLEANING. THE IMPLANT IS THREADED AND NEEDS TO BE RETHREADED. OK TO SEND PART NEXT WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21166 IMPL TAPERED SCR-V SBM 6M M 5.7MM 13MM DENTAL IMPLANT DZE ZIMVIE US CORP LLC 60634931

    Patients

    Seq Age Sex Outcome Treatment
    1