BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,MCOL MG,4.7MM,11.5MML

    MDR report key: 24730393 · Received March 30, 2026

    Report

    Report Number
    0001038806-2026-01696
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    February 22, 2026
    Report Date
    May 14, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024019782
    PMA / PMN Number
    K111889
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). G4: PREMARKET IDENTIFICATION PMA/510(K) #: K101880.

    Description of Event or Problem · 0

    THE DOCTOR REPORTS THAT THE DENTAL IMPLANT FAILED BECAUSE IT FRACTURED AT THE HEAD.THE DOCTOR REPORTS THAT THE PROCEDURE WAS CONCLUDED BY PLACING ANOTHER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265035 IMP,TSV,MCOL MG,4.7MM,11.5MML DENTAL IMPLANT DZE ZIMVIE US CORP LLC 1257639 00889024019782

    Patients

    Seq Age Sex Outcome Treatment
    1