BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIMESH CRUCIATE, SELF-DRILLING SCREWS

    MDR report key: 2826109 · Received November 5, 2012

    Report

    Report Number
    2021898-2012-00362
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Date of Event
    September 10, 2012
    Report Date
    October 8, 2012
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    HWC
    PMA / PMN Number
    K062348
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO MEDTRONIC NEUROSURGERY. THEREFORE, DEVICE PERFORMANCE EVAL WAS NOT POSSIBLE. A REVIEW OF MFG RECORDS SHOWED NO ANOMALIES. THERE WAS NO REPORTED IMPACT TO THE PT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT DURING A SURGERY, THE SCREW HEAD BROKE APART FROM THE SCREW BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIMESH CRUCIATE, SELF-DRILLING SCREWS HWC - SCREW, FIXATION, BONE HWC MEDTRONIC NEUROSURGERY TV08051

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR