BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,MCOL MG,4.7MM,8MM

    MDR report key: 24924460 · Received April 20, 2026

    Report

    Report Number
    0001038806-2026-02133
    Event Type
    Injury
    Date Received
    April 20, 2026
    Date of Event
    March 31, 2026
    Report Date
    May 14, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024019812
    PMA / PMN Number
    K111889
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4) A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED . G4: ADDITIONAL PMA/510(K) NUMBER K101880.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #29 WAS REMOVED DUE TO BONE LOSS. PT CAME IN FOR A LOOSE BRIDGE. IN EXAMINING WE REMOVED THE BRIDGE & LOOSE IMPLANT CAME OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216636 IMP,TSV,MCOL MG,4.7MM,8MM DENTAL IMPLANT DZE ZIMVIE US CORP LLC 1255018 00889024019812

    Patients

    Seq Age Sex Outcome Treatment
    1