BEUDAMED
    FDA Adverse Event Death Summary report: N

    2520274-2013-05624

    MDR report key: 3318120 · Received August 29, 2013

    Report

    Report Number
    2520274-2013-05624
    Event Type
    Death
    Date Received
    August 29, 2013
    Date of Event
    October 28, 2012
    Report Date
    July 31, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO SUSPECTED ASSOCIATION BETWEEN DEATH AND THE USE OF THE PRODUCT THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    JOURNAL ARTICLE RECEIVED: INTERTROCHANTERIC FRACTURES: COMPARISON BETWEEN TWO DIFFERENT LOCKING NAILS, INTERNATIONAL ORTHOPAEDICS (SICOT) (2012) 36:2545¿2551 REPORTED: A STUDY THAT COMPARED 46 TGN (STRYKER HOWMEDICA) AND 51 PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) (SYNTHES) USED IN THE TREATMENT OF INTERTROCHANTERIC FRACTURES BETWEEN 2006 AND 2007. THE MEAN AGE OF THE PFNA GROUP WAS 81.7. IT WAS REPORTED THAT IN FIVE OF THE PFNA CASES, DEATH WITHIN THE FIRST SIX MONTHS OCCURRED. NO FURTHER INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4). THIS REPORT IS FOR THE UNKNOWN END CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425496 KTT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other