BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM TI VA LOCKING SCREW STARDRIVE 18MM

    MDR report key: 3091440 · Received May 3, 2013

    Report

    Report Number
    2520274-2013-02335
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K103243
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THIS SCREW IS WHOLE AND INTACT. THE DIAMETER OF 2.38MM, STARDRIVE, THREADED HEAD, FLUTES, AND 18.38MM LENGTH CONFIRM THIS AS A 04.210.118. THE DRIVE IS IN GOOD CONDITION. THE TOP OF THE HEAD IS ALSO IN GOOD CONDITION. THE HEAD THREADS HAVE BEEN LIGHTLY DAMAGED IN THE FORM OF COMPRESSION OF THE MAJOR DIAMETER INTO A T. THIS DAMAGE AFFECTS PROFILE. THE FIRST THREE SHAFT THREADS HAVE THE ANODIZE COATING REMOVED. THE REMAINDER OF THE SHAFT THREADS ARE IN GOOD CONDITION, AS ARE THE FLUTES AND TIP. THE DIMENSIONS THAT COULD BE CHECKED WERE FOUND ACCEPTABLE. BECAUSE OF DAMAGE INCURRED, AND ALSO BECAUSE NO LOT NUMBER WAS PROVIDED, A FINITE EVALUATION COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Description of Event or Problem · 1

    A VOLAR PLATE WAS IMPLANTED ON AN UNKNOWN DATE. ON AN UNKNOWN DATE, THE PLATE PULLED AWAY FROM THE BONE CAUSING THE PATIENT PAIN. THE SURGEON PERFORMED A HARDWARE REMOVAL OF THE PLATE AND SEVEN SCREWS ON (B)(6) 2013. A LARGER PLATE AND NINE SCREWS WERE IMPLANTED INSTEAD. THE SURGEON REPORTED STRONGER FIXATION WITH THE NEW HARDWARE. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 8 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194104 2.4MM TI VA LOCKING SCREW STARDRIVE 18MM HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention