BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP AV SBM 3.7MM 4.5MM IN TERFACE 10MM

    MDR report key: 24702062 · Received March 26, 2026

    Report

    Report Number
    0001038806-2026-01629
    Event Type
    Injury
    Date Received
    March 26, 2026
    Date of Event
    March 13, 2026
    Report Date
    May 11, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024013865
    PMA / PMN Number
    K002614
    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 K011245. H6: ADDITIONAL H6- PATIENT CODES: 1932: INFLAMMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #23 WAS REMOVED DUE TO PERI-IMPLANTITIS SYMPTOMS AS A RESULT OF THE EVENT: PAIN & INFLAMMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5590 IMP AV SBM 3.7MM 4.5MM IN TERFACE 10MM DENTAL IMPLANT DZE ZIMVIE US CORP LLC 63254218 00889024013865

    Patients

    Seq Age Sex Outcome Treatment
    1