BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABILIZATION

    MDR report key: 20072567 · Received August 26, 2024

    Report

    Report Number
    3007593722-2024-00011
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    August 6, 2024
    Report Date
    August 26, 2024
    Manufacturer
    MEDSHAPE, INC.
    Product Code
    HWC
    UDI-DI
    00810028390348
    PMA / PMN Number
    D356720
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 2.2X16 NON LOCKING SCREW HEAD BROKE WHILE TIGHTENING INTO A 5 HOLE MINI PLATE, PIECE LEFT IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25315 SABILIZATION 2.2MM X 16MM ARSENAL SCREW HWC MEDSHAPE, INC. 05876 00810028390348

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Unknown Other