BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM/3.5MM VA-LCP EXT MEDL DSTL HUM PL 6H/LT/137MM-XLNG

    MDR report key: 2924800 · Received January 22, 2013

    Report

    Report Number
    8030965-2013-00174
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    October 24, 2012
    Report Date
    December 26, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K120070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH TWO DISTAL HUMERUS PLATES AND SCREW CONSTRUCT ON (B)(6) 2012, DUE TO COMMINUTED FRACTURE FROM A GUNSHOT. POST-OPERATIVE X-RAY REVEALED TWO BROKEN PLATES, TWO BROKEN SCREWS, AND THREE SCREWS SITTING PROUD. SURGEON REPORTS THAT HARDWARE BROKE ON (B)(6) 2012. PATIENT RETURNED TO THE O.R. ON (B)(6) 2012 FOR REMOVAL OF HARDWARE. PATIENT WAS REVISED WITH NEW HARDWARE AND GRAFT FROM FEMUR. THIS IS 1 OF 7 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31107 2.7MM/3.5MM VA-LCP EXT MEDL DSTL HUM PL 6H/LT/137MM-XLNG PLATE HRS SYNTHES GMBH 7802902

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention SCREWS