BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOLOCK EX-PIN 3X110

    MDR report key: 3900244 · Received June 27, 2014

    Report

    Report Number
    0001811755-2014-02301
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAW
    PMA / PMN Number
    K022365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD NOT BE CONFIRMED AS THE PINS WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION. DEVICE NOT RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT QUANTITY 2 OF THE ORTHOLOCK EX-PIN 3X110 BROKE UPON REMOVAL FROM THE TIBIA DURING A PROCEDURE. THE BROKEN FRAGMENTS WERE LEFT IN THE PATIENT'S BONE. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THE EVENT AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376368 ORTHOLOCK EX-PIN 3X110 NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW STRYKER INSTRUMENTS-KALAMAZOO F12049

    Patients

    Seq Age Sex Outcome Treatment
    1