BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD, FIXATION, INTRAMEDULLARY

    MDR report key: 4222748 · Received November 4, 2014

    Report

    Report Number
    2520274-2014-14446
    Event Type
    Injury
    Date Received
    November 4, 2014
    Report Date
    October 7, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN HELICAL BLADE. ADDITIONAL PRODUCT CODE: HWC. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT IMPLANTATION OF A TROCHANTERIC FIXATION NAIL, HELICAL BLADE AND SCREW IN (B)(6) 2014. THE PATIENT SUBSEQUENTLY EXPERIENCED PAIN, IRRITATION AND DISCOMFORT AND UNDERWENT A REVISION TO BIPOLAR HIP ON (B)(6), 2014. THERE WERE NO DEVICE RELATED ISSUES; ALL DEVICES WERE REMOVED EASILY AND WITHOUT INCIDENT. THE PATIENT OUTCOME WAS REPORTED AS GOOD. THIS REPORT IS FOR AN UNKNOWN HELICAL BLADE. THIS IS REPORT NUMBER 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707779 ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention