BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 11694418 · Received April 20, 2021

    Report

    Report Number
    3012165443-2021-00004
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    April 16, 2021
    Report Date
    April 20, 2021
    Manufacturer
    QUALITY TECH SERVICES LLC
    Product Code
    HAW
    UDI-DI
    00643169702912
    PMA / PMN Number
    K971247
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION INSTRUMENT USED DURING A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT WHEN SITE PUT THE BASE FOR THE GUIDE KIT, THE SURGEON PUT A LOT OF PRESSURE ON THE SCREWS WHEN ATTACHING THE BASE. USED AN EXTERNAL STRAIGHT BASE. AT THE END OF THE PROCEDURE, HE BROKE OFF ONE OF THE SCREWS. ABOUT HALF THE SCREW WAS LEFT IN THE PATIENT'S SKULL. SURGEON TRIED TO GRAB THE 1MM THAT WAS STICKING OUT AND BROKE THAT PIECE OFF ALSO. IT WAS ESTIMATED THAT ONLY A COUPLE MM WERE LEFT. THE SURGEON DECIDED TO LEAVE IT BECAUSE IT WAS CLOSE TO THE BURR HOLE AND COVERED IT WITH A BURR HOLE COVER. THERE WAS ABOUT 5 MINUTES DELAY TO THE PROCEDURE. IMPACT ON PATIENT OUTCOME IS NOT KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593523 N/A INSTRUMENT, STEREOTAXIC HAW QUALITY TECH SERVICES LLC 9733065 066229320 00643169702912

    Patients

    Seq Age Sex Outcome Treatment
    1