BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM LCP DISTAL RADIUS T-PLATE 3H HEAD/4H SHAFT

    MDR report key: 2902479 · Received January 8, 2013

    Report

    Report Number
    2520274-2013-00185
    Event Type
    Injury
    Date Received
    January 8, 2013
    Report Date
    December 11, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K091644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    NURSE

    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 WAS IMPLANTED WITH LCP DISTAL RADIUS T-PLATE AND SCREW CONSTRUCT ON (B)(6) 2012 FOLLOWING AN INJURY ON (B)(6) 2012. REPORTEDLY THE SURGEON PLACED THE HARDWARE TOO FAR INTO THE ULNAR AND SUBSEQUENTLY CAUSED IMPINGEMENT ON THE PATIENT'S PRONATION SUPINATION. THE PATIENT COULD NOT TURN HER HAND ALL THE WAY OVER AND WAS HAVING PAIN. PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012 FOR REMOVAL OF HARDWARE. REPORTEDLY THE PATIENT WAS HEALED. THE IMPLANT DID NOT FAIL AND NOTHING WAS BROKEN. THE IMPLANTS WERE REMOVED WITH NO PROBLEMS. THIS IS 1 OF 5 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9640 2.4MM LCP DISTAL RADIUS T-PLATE 3H HEAD/4H SHAFT LCP DISTAL RADIUS T-PLATE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention SCREWS