BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREWS, CROSS-PIN, DIAM.2.0X5MM, (5/PACKAGE)

    MDR report key: 5138554 · Received October 8, 2015

    Report

    Report Number
    0008010177-2015-00252
    Event Type
    Malfunction
    Date Received
    October 8, 2015
    Date of Event
    September 10, 2015
    Report Date
    September 10, 2015
    Manufacturer
    STRYKER LEIBINGER FREIBURG (MDR)
    Product Code
    JEY
    PMA / PMN Number
    K022185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DEVICE WAS UNABLE TO BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT WHILE USING THE LOCKING SCREW (#50-20505) WITH THE MINI PLATE (#55-10505), A SLIVER OF THE PLATE WAS SHAVED OFF WHILE THE SURGEON WAS ENGAGING THE SCREW. HE NOTED THAT IT WAS NOT LOCKING (CATCHING) PROPERLY. THE SLIVER IS NOT AVAILABLE TO RETURN, AND THE PLATE WAS LEFT IMPLANTED IN THE PATIENT. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669971 LOCKING SCREWS, CROSS-PIN, DIAM.2.0X5MM, (5/PACKAGE) IMPLANT JEY STRYKER LEIBINGER FREIBURG (MDR) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1