BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-06119

    MDR report key: 3329531 · Received September 6, 2013

    Report

    Report Number
    2520274-2013-06119
    Event Type
    Injury
    Date Received
    September 6, 2013
    Report Date
    August 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF EVENT: 2012 DEC; 27(10):1006-10. 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

    A JOURNAL ARTICLE WAS RECEIVED ENTITLED, AUXILIARY LOCKING PLATE IMPROVES FRACTURE STABILITY AND HEALING IN INTERTROCHANTERIC FRACTURES FIXATED BY INTRAMEDULLARY NAIL SEBASTIAN EBERLE , JOHANNES GABEL , SVEN HUNGERER, STEFANIE HOFFMANN, ROBERT PÄTZOLD, PETER AUGAT, VOLKER BÜHREN, CLINICAL BIOMECHANICS 27 (2012) 1006¿1010. THIS STUDY DESCRIBES THE RESULTS OF 13 PATIENTS WITH UNSTABLE INTERTROCHANTERIC OR SUBTROCHANTERIC NONUNIONS WHO WERE TREATED BY REVISION SURGERY. THEIR INITIAL IMPLANTS WERE REPLACED BY THE LONG GAMMA NAIL AND ADDITIONAL LOCKING COMPRESSION PLATE (LCP). FOUR FEMALE AND NINE MALE PATIENTS WITH AN AVERAGE AGE OF 55.4 YEARS WERE STUDIED. POSTOPERATIVELY, ONE PATIENT EXPERIENCED A REFRACTURE AND ONE PATIENT DEVELOPED AN INFECTION AND NONUNION. THIS REPORT IS FOR A SCREW. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443666 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention