BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-03032

    MDR report key: 3140730 · Received May 31, 2013

    Report

    Report Number
    2520274-2013-03032
    Event Type
    Injury
    Date Received
    May 31, 2013
    Report Date
    May 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE DEVICE WAS IMPLANTED ON AN UNKNOWN DATE IN JANUARY 2013. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    REVISION SURGERY TOOK PLACE ON (B)(6) 2013. ALL HARDWARE WAS REMOVED AND REPLACED WITH A LONG TROCHANTERIC FIXATION NAIL (TFN). NO ISSUES DURING SURGERY WERE REPORTED.

    Description of Event or Problem · 1

    PATIENT UNDERWENT TROCHANTERIC FIXATION NAIL (TFN) SURGERY ON AN UNKNOWN DATE IN (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT WAS COMPLAINING OF PAIN. BOTH AN MRI AND AN X-RAY REVEALED THE DISTAL INTERLOCK SCREW IS POSTERIOR TO THE NAIL AND IS NOT ENGAGED IN THE NAIL. REVISION SURGERY IS PLANNED FOR THE NEAR FUTURE. THIS REPORT IS FOR AN UNKNOWN SCREW. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241600 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention