BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM

    MDR report key: 3132296 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02379
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 1, 2013
    Report Date
    April 30, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTW
    PMA / PMN Number
    K011815
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. APPROXIMATE IMPLANT DATE REPORTED AS SIX OR SEVEN MONTHS PRIOR TO EXPLANT DATE (B)(6) 2012). INVESTIGATION IS ON GOING; NO CONCLUSION CAN BE DRAWN AS NO DEVICE WAS RETURNED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    APPROXIMATELY SIX TO SEVEN MONTHS AGO ((B)(6) 2012), PATIENT FELL AND REQUIRED AN ORIF PROCEDURE TO REPAIR THE RIGHT PROXIMAL HUMERUS. PATIENT WAS IMPLANTED WITH AN LCP PROXIMAL HUMERUS PLATE, 3.5MM LOCKING SCREWS AND 3.5MM CORTICAL SCREWS. PATIENT COMPLAINED OF POSTOPERATIVE PAIN AND SURGEON DIAGNOSED PATIENT WITH SYMPTOMATIC HARDWARE ISSUES. X-RAYS TAKEN ON (B)(6) 2013 CONFIRMED DIAGNOSIS OF HARDWARE ISSUES THAT HAD BEEN NOTED TWO WEEKS PRIOR. X-RAYS SHOWED THAT FOUR PROXIMAL LOCKING SCREWS HAD MIGRATED AND WERE PROTRUDING INTO THE JOINT. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2013 TO REMOVE ALL HARDWARE. NO BROKEN HARDWARE NOTED. THERE WAS MINIMAL BLOOD LOSS DURING SURGERY, AND TOTAL SURGERY TIME WAS 15 MINUTES. THE PATIENT WAS EXAMINED BY FLUOROSCOPIC X-RAY POSTOPERATIVELY AND APPEARED HEALED. AS PER THE HOSPITAL, ALL REMOVED HARDWARE WILL BE RETAINED BY THE PATHOLOGY DEPARTMENT AND ARE NOT AVAILABLE FOR RETURN. THIS IS 1 OF 3 REPORTS FOR THE SAME EVENT, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236526 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM APPLIANCE, FIXATION,NAIL/BLADE/PLATE COMBO KTW SYNTHES GMBH 7901873

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention