BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREWS, CROSS-PIN, DIAM 2.0X10MM, (5/PACKA

    MDR report key: 1847349 · Received September 28, 2010

    Report

    Report Number
    8010177-2010-00348
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    October 15, 2009
    Report Date
    August 30, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K014263
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS, BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLATE AND SCREW WERE USED ON (B)(6) OF 2009. AFTER THE OPERATION, IN (B)(6) 2009, THE PT AND DR NOTICED THAT THE 5 SCREWS OUT OF 9 SCREWS WERE BROKEN AND THE PLATE WAS LOOSE. THE REMOVAL AND REPLACEMENT OPERATION WAS FINISHED IN (B)(6) 2009 WITHOUT ANY PROBLEMS. THESE BROKEN SCREWS ARE ONE OF EACH 21-20508, 21-20510, 21-20508. THE 1 OF 5 BROKEN SCREWS WERE LOST. THE SURGEON INFORMED THE STRYKER SALES REP OF THIS EVENT ON AUGUST 30 OF 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING SCREWS, CROSS-PIN, DIAM 2.0X10MM, (5/PACKA IMPLANT JEY STRYKER OSTEOSYNTHESIS FREIBURG NA 00090605R

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other