BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM CANNULATED LOCKING SCREW

    MDR report key: 2171059 · Received July 8, 2011

    Report

    Report Number
    2520274-2011-00234
    Event Type
    Injury
    Date Received
    July 8, 2011
    Report Date
    June 13, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS NOT PROVIDED DURING INITIAL REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING SITE OR MANUFACTURING DATE WITHOUT A PART NUMBER OR A LOT NUMBER. SYNTHES IS UNABLE TO DETERMINE 510(K) # WITHOUT A PART NUMBER OR A LOT NUMBER. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    STATUS POST PERIPROSTHETIC MIDSHAFT FEMUR FRACTURE, DISTAL TO A TOTAL HIP. SECOND NON-UNION SURGERY. FIRST NON-UNION WAS ONE YEAR AGO. PATIENT COMPLAINED OF PAIN IN RIGHT FEMUR. REVISION DUE TO NONUNION. PATIENT REVISED TO PLATE AND SCREWS. THIS IS THE 4TH OF 18 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.0MM CANNULATED LOCKING SCREW CANNULATED LOCKING SCREW HWC SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PLATE| CABLES| SCREWS