BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPIC POSTERIOR SPINAL FIXATION SYSTEM

    MDR report key: 17672673 · Received September 1, 2023

    Report

    Report Number
    3011764740-2023-00001
    Event Type
    Malfunction
    Date Received
    September 1, 2023
    Date of Event
    May 26, 2023
    Report Date
    September 1, 2023
    Manufacturer
    ASTURA MEDICAL
    Product Code
    NKB
    UDI-DI
    00841379176688
    PMA / PMN Number
    K182239
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE LOCKING SET SCREWS FOR THE OLYMPIC POSTERIOR SPINAL FIXATION SCREW SYSTEM BACKED OUT OF THE INSERTED PEDICLE SCREWS IN THE PATIENT. THIS WAS DISCOVERED DURING A POST-OP X-RAY AND A REVISION SURGERY WAS PERFORMED TO REPLACE THE REMOVED SET SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986790 OLYMPIC POSTERIOR SPINAL FIXATION SYSTEM THORACOLUMBOSACRAL PEDICALE SCREW SYSTEM NKB ASTURA MEDICAL ABBA00000 635601A 00841379176688

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention