BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTICAL POLYAXIAL SCREW, CANNULATED 7.5MM X 45MM

    MDR report key: 18847511 · Received March 6, 2024

    Report

    Report Number
    3015941638-2024-00005
    Event Type
    Injury
    Date Received
    March 6, 2024
    Date of Event
    February 8, 2024
    Report Date
    March 5, 2024
    Manufacturer
    ASTURA MEDICAL
    Product Code
    OSH
    UDI-DI
    00841379124054
    PMA / PMN Number
    K153446N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    N/A.

    Description of Event or Problem · 0

    A SCREW BROKE WHILE IMPLANTED. (POST-OP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117738 CORTICAL POLYAXIAL SCREW, CANNULATED 7.5MM X 45MM POLYAXIAL SCREW OSH ASTURA MEDICAL AARA75045 219224C 00841379124054

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention