BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOLOCK EX-PIN 3X110

    MDR report key: 3833008 · Received May 27, 2014

    Report

    Report Number
    0001811755-2014-01937
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAW
    PMA / PMN Number
    K022365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT YET RETURNED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT THAT THE PIN BROKE WAS NOT CONFIRMED AS THE PRODUCT FOR THIS INVESTIGATION WAS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ORTHOLOCK EX-PIN 3X110 BROKE OFF INTO THE PATIENT DURING A PROCEDURE. THE PIN BROKE DURING REMOVAL FROM THE TIBIA AND 2 MM OF THE PIN WAS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ORTHOLOCK EX-PIN 3X110 BROKE OFF INTO THE PATIENT DURING A PROCEDURE. THE PIN BROKE DURING REMOVAL FROM THE TIBIA AND 2 MM OF THE PIN WAS 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
    311711 ORTHOLOCK EX-PIN 3X110 NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1