BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SP 3.7MM 8MM OCTAGON

    MDR report key: 13250979 · Received January 13, 2022

    Report

    Report Number
    0002023141-2022-00079
    Event Type
    Injury
    Date Received
    January 13, 2022
    Date of Event
    October 13, 2021
    Report Date
    January 13, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024017207
    PMA / PMN Number
    K082639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). PMA/510(K) NUMBER K011245 AND K002188.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT WOULD HAVE TO RETURN TO PLACE A NEW IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016394 IMPL TAPERED SP 3.7MM 8MM OCTAGON DENTAL IMPLANT DZE ZIMMER DENTAL SPB8 2019060122 00889024017207

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention