BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM

    MDR report key: 2931110 · Received January 28, 2013

    Report

    Report Number
    1719045-2013-00204
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    November 15, 2012
    Report Date
    January 8, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HRS
    PMA / PMN Number
    K112583
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT SUFFERED A WRIST FRACTURE AND WAS IMPLANTED WITH PLATE AND SCREW CONSTRUCT ON (B)(6) 2012. ON (B)(6) 2012, PATIENT FELL AND RE-FRACTURED THE WRIST, BENDING THE PREVIOUSLY IMPLANTED PLATE. PATIENT RETURNED TO THE OR ON (B)(6) 2013 FOR REMOVAL OF HARDWARE. PATIENT WAS REVISED WITH A LONGER PLATE. THIS IS 3 OF 8 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36610 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM CORTEX SELF TAPPING SCREW HRS SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention