BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM LOCKING SCREW

    MDR report key: 2171077 · Received July 8, 2011

    Report

    Report Number
    2520274-2011-00242
    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 INFO WAS NOT PROVIDED DURING INITIAL REPORT. ADD'L INFO HAS BEEN REQUESTED. SYNTHES IS UNABLE TO DETERMINE MFG SITE OR MFG DATE WITHOUT A PART NUMBER OR A LOT NUMBER. SYNTHES IS UNABLE TO DETERMINE 510(K) # WITHOUT A PART NUMBER OR 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 1 YEAR AGO. PT COMPLAINED OF PAIN IN RIGHT FEMUR. REVISION DUE TO NON-UNION. PT REVISED TO PLATE AND SCREWS. THIS IS THE 12TH OF 18 REPORTS SUBMITTED ON THIS EVENT.

    Devices

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

    Patients

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