BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOLOCK EX-PIN 3X110

    MDR report key: 2942051 · Received December 27, 2012

    Report

    Report Number
    3007582679-2012-00056
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 3, 2012
    Manufacturer
    STRYKER NAVIGATION
    Product Code
    HAW
    PMA / PMN Number
    K022579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE EVENT WITHOUT AN EVALUATION OF THE DEVICE. ADDITIONAL INFORMATION WILL BE SUBMITTED WHEN THE DEVICE IS RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ORTHOLOCK EX-PIN BROKE DURING A PROCEDURE. THE BROKEN PIN WAS RETRIEVED. NO ADVERSE EVENT WAS ASSOCIATED WITH DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOLOCK EX-PIN 3X110 HAW STRYKER NAVIGATION 10053

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK