BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-05838

    MDR report key: 3318084 · Received August 29, 2013

    Report

    Report Number
    2520274-2013-05838
    Event Type
    Injury
    Date Received
    August 29, 2013
    Report Date
    July 31, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    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. NO SUSPECTED ASSOCIATION BETWEEN DEATH AND THE USE OF THE PRODUCT. DATE OF EVENT: 2010; 44 (2):127-134. 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 TITLED: RADIOGRAPHIC AND FUNCTIONAL RESULTS OF OSTEOSYNTHESIS USING THE PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) IN THE TREATMENT OF UNSTABLE INTERTROCHANTERIC FEMORAL FRACTURES; SAHIN S., ERTURER E., OZTURK I., TOKER S., SECKIN F., AKMAN S.; ACTA ORTHOPAEDICA ET TRAUMATOLOGICA TURCICA. (2010); 44 (2):127-134. REPORTEDLY: POSTOPERATIVELY, SIX PATIENTS DIED. CAUSE OF DEATH WAS NOT REPORTED. ONE PATIENT DIED ONE MONTH POSTOPERATIVELY, THREE PATIENTS DIED SIX MONTHS POSTOPERATIVELY AND TWO PATIENTS DIED IN THE FIRST YEAR. DEVICE WAS REPORTED AS SYNTHES PRODUCT. THIS REPORT IS FOR A BLADE OF THE PFNA SYSTEM. THIS IS 1 OF 4 REPORTS FOR THE SAME EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425295 HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other