BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-02362

    MDR report key: 3092519 · Received May 3, 2013

    Report

    Report Number
    2520274-2013-02362
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    IT WAS REPORTED PATIENT HAD A SUBTROCHANTERIC FEMUR FRACTURE APPROXIMATELY 4 MONTHS AGO, AND WAS IMPLANTED WITH A DCS PLATE ALONG WITH LAG, COMPRESSION AND CORTEX SCREWS. A REVISION SURGERY WAS PERFORMED ON PATIENT ON (B)(6) 2013, DUE TO PATIENT EXPERIENCING LEFT SUBTRONCHANTERIC NON-UNION RESULTING IN BREAKING OF DCS PLATE. THE DCS PLATE, AS WELL AS LAG, COMPRESSION, AND CORTEX SCREWS WERE REMOVED. NO FURTHER INFORMATION IS AVAILABLE. IT WAS ALSO REPORTED THE PATIENT IS DIABETIC AND OBESE. THIS REPORT IS FOR AN UNKNOWN COMPRESSION SCREW. THIS IS 4 OF 8 DEVICES FOR THIS EVENT REPORTED ON (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194241 HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention