BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOLOCK EX-PIN 3X110

    MDR report key: 3893669 · Received June 25, 2014

    Report

    Report Number
    0001811755-2014-02262
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAW
    PMA / PMN Number
    K022365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORTHOLOCK EX-PIN 3X110 WAS DISPOSED OF AT THE TIME OF THE PROCEDURE AT THE USER FACILITY. THE DEVICE IS THEREFORE UNAVAILABLE FOR ROOT CAUSE EVALUATION. DEVICE NOT RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUSTAINED A TIBIAL FRACTURE AT THE LOCATION OF THE ORTHOLOCK EX-PIN 3X110 INSERTION SITE AFTER A PROCEDURE. THIS WAS DISCOVERED DURING THE POSTOPERATIVE CHECKUP WITH THE SURGEON. THE ORIGINAL CASE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. DURING THE POSTOPERATIVE VISIT, THE PATIENT COMPLAINED OF PAIN IN HER TIBIA. THE PAIN WAS TREATED WITH A KNEE BRACE AND AN X-RAY WAS TAKEN, WHICH CONFIRMED A FRACTURE AT THE TIBIAL PIN SITE. THE PATIENT MET WITH THE SURGEON THREE WEEKS LATER AND IT WAS DETERMINED THAT AN OPEN REDUCTION INTERNAL FIXATION SURGERY WAS NEEDED TO CORRECT THE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370499 ORTHOLOCK EX-PIN 3X110 NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R