BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICASE

    MDR report key: 14572409 · Received June 2, 2022

    Report

    Report Number
    3005718816-2022-00002
    Event Type
    Injury
    Date Received
    June 2, 2022
    Date of Event
    April 12, 2022
    Report Date
    May 19, 2022
    Manufacturer
    MATERIALISE USA, LLC
    Product Code
    PBF
    UDI-DI
    E314UEAMA0100010
    PMA / PMN Number
    K163156
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ONGOING. DEVICES DISCARDED AT HOSPITAL.

    Additional Manufacturer Narrative · 0

    DEVICES MET SPECIFICATIONS AND NO ROOT CAUSE COULD BE DETERMINED. SURGERY WAS COMPLEX (MONTEGGIA CASE), WHICH COULD HAVE PLAYED A ROLE. H3: RETURN OF DEVICE REQUESTED BUT NOT RECEIVED.

    Description of Event or Problem · 0

    OSTEOTOMIES COULD NOT BE EXECUTED AS PLANNED AND SURGEON HAD TO ADAPT INTRA-OPERATIVELY. SURGEON DID REVISION SURGERY LATER ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2438480 SURGICASE PEDIATRIC RADIUS/ULNA OSTEOTOMY GUIDE AND MODEL PBF MATERIALISE USA, LLC UEA-MA01-00-01 OO22RICNIJ E314UEAMA0100010

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Male Other