BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICASE

    MDR report key: 11670071 · Received April 15, 2021

    Report

    Report Number
    3005718816-2021-00001
    Event Type
    Injury
    Date Received
    April 15, 2021
    Date of Event
    February 26, 2021
    Report Date
    March 18, 2021
    Manufacturer
    MATERIALISE USA, LLC
    Product Code
    PBF
    UDI-DI
    E314UEAMA0100010
    PMA / PMN Number
    K163156
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICES MET SPECIFICATIONS AND NO ROOT CAUSE COULD BE DETERMINED. PATIENT HAD PRE-EXISTING MEDICAL CONDITION THAT COULD HAVE PLAYED A ROLE. H3: RETURN OF DEVICE REQUESTED BUT NO REPLY RECEIVED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION ONGOING.

    Description of Event or Problem · 1

    EXPECTED OUTCOME OF RADIUS AND ULNA CORRECTION NOT MET AND MOST LIKELY REVISION SURGERY WILL BE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573512 SURGICASE RADIUS/ULNA OSTEOTOMY, PEDIATRIC PBF MATERIALISE USA, LLC UEA-MA01-00-01 OO21ENIOZA E314UEAMA0100010

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other