BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-05358

    MDR report key: 3330582 · Received September 6, 2013

    Report

    Report Number
    2520274-2013-05358
    Event Type
    Malfunction
    Date Received
    September 6, 2013
    Report Date
    August 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Description of Event or Problem · 1

    JOURNAL ARTICLE RECEIVED: INTRA- AND PERIOPERATIVE COMPLICATIONS IN THE STABILIZATION OF PER-AND SUBTROCHANTERIC FEMORAL FRACTURES BY MEANS OF PFN. UNFALLCHIRURG: DECEMBER 2002: VOLUME 105, ISSUE 10: PP.881-885. AUTHORS: W. WERNER-TUTSCHKU, G. LAJTAI, G. SCHMIEDHUBER, T. LAING, C. PROKL, AND E. ORTHNER. THIS ARTICLE DOES MENTION SYNTHES. PLEASE SEE PAGE 882 OF ATTACHED ARTICLE FOR ENGLISH. STUDY IS FROM FEBRUARY 1998 TO JUNE 1999: 70 PATIENTS TREATED WITH PFN NAILS. IT WAS REPORTED: 5 CASES Z EFFECT AND 6 CASES: CUT OUT OF SLIDING HIP SCREW. THIS COMPLAINT IS ON THE 5 CASES OF Z EFFECT. (UNKNOWN SCREW) THIS IS 3 OF 3 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443732 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1