BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-05813

    MDR report key: 3318059 · Received August 29, 2013

    Report

    Report Number
    2520274-2013-05813
    Event Type
    Injury
    Date Received
    August 29, 2013
    Report Date
    July 31, 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: 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: LATE POSTOPERATIVE COMPLICATION OF LATERAL DISPLACEMENT OF SCREWS IN FIVE PATIENTS WAS REPORTED. DISPLACEMENT WAS LESS THAN 5MM IN FOUR PATIENTS AND 15MM TO THE LATERAL IN ONE PATIENT. DEVICE WAS REPORTED AS SYNTHES PRODUCT. THIS REPORT IS FOR A SCREW OF THE PFNA SYSTEM. THIS IS 3 OF 4 REPORTS FOR THE SAME EVENT, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425128 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention