BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICASE

    MDR report key: 9361713 · Received November 22, 2019

    Report

    Report Number
    3005718816-2019-00001
    Event Type
    Injury
    Date Received
    November 22, 2019
    Date of Event
    July 11, 2019
    Report Date
    October 30, 2019
    Manufacturer
    MATERIALISE USA, LLC
    Product Code
    PBF
    UDI-DI
    E314O01010100000110100
    PMA / PMN Number
    K112389
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE INTERNAL DOCUMENTATION AND THE DEVICE DID NOT SHOW AN ANOMALY OR DEVIATION. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    REVISION SURGERY NEEDED AS PLANNED OUTCOME WAS NOT MET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157602 SURGICASE SURGICASE GUIDE PBF MATERIALISE USA, LLC O-01-0-101000-0011-010 OO19UDEHEZ E314O01010100000110100

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other