BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA-II BLADE L90 TAN

    MDR report key: 2844017 · Received November 24, 2012

    Report

    Report Number
    2520274-2012-03213
    Event Type
    Injury
    Date Received
    November 24, 2012
    Date of Event
    December 30, 2008
    Report Date
    January 20, 2009
    Manufacturer
    SYNTHES
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED (B)(4) 2011. A REVIEW OF THE EVENTS ASSOCIATED WITH THE REQUEST WAS PERFORMED AND IT WAS DETERMINED THAT NONE OF THE EVENTS CONSTITUTES SYSTEMIC ISSUES RELATED TO PRODUCT QUALITY, CHANGES IN PRODUCT DESIGN, METHOD OF USE, OR CHANGES IN EXPECTED RISK THRESHOLDS. REVIEW OF THE DATA ALSO INDICATED NO SIGNIFICANT CHANGE IN RISK/BENEFIT OF EACH PRODUCT CATEGORY, NO EVIDENCE OF DEFICIENCIES IN THE DESIGN, LABELING, OR MANUFACTURE OF THE DEVICE. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    (B)(4) COMPLAINT HANDLING UNIT REPORTED A BLADE BACK-OUT. TROCHANTERIC FRACTURE WAS TREATED WITH PROXIMAL FEMORAL NAIL ANTIROTATION-II ON (B)(6) 2008. AFTER THE OPERATION, WEIGHT BEARING WAS PERMITTED. THE PATIENT'S ABILITY TO WALK WAS NOT GOOD SINCE BEFORE THE OPERATION, SO SHE WALKED WITH CASTER WALKER AFTER THE OPERATION. FROM AROUND (B)(6) 2009 THE PATIENT FELT PAIN. INSPECTION BY X-RAYS REVEALED BLADE BACK-OUT. ON (B)(6) 2009, THE NAIL WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFNA-II BLADE L90 TAN PFNA-II BLADE HSB SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention