BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-01567

    MDR report key: 3010179 · Received March 19, 2013

    Report

    Report Number
    2520274-2013-01567
    Event Type
    Injury
    Date Received
    March 19, 2013
    Report Date
    February 23, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SEX: FEMALE. IT WAS REPORTED X-RAYS WERE TAKEN ON AN UNKNOWN DATE.

    Additional Manufacturer Narrative · 1

    DATE OF IMPLANT UNKNOWN. REPORTEDLY THE DEVICE WAS IMPLANTED 6 YEARS AGO (2007). DATE OF EXPLANT IS UNKNOWN. SCHEDULED REMOVAL OF HARDWARE DURING THE WEEK OF (B)(6) 2013. 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

    PATIENT WAS IMPLANTED WITH NAIL AND SPIRAL BLADE ON AN UNKNOWN DATE APPROXIMATELY SIX YEARS AGO (2007). THE SURGEON REPORTED THE PATIENT HAD FALLEN RECENTLY, DATE UNKNOWN. X-RAY TAKEN ON AN UNKNOWN DATE SHOWED NO SIGN OF BREAKAGE OF THE NAIL. THE PATIENT IS SCHEDULED FOR REMOVAL OF HARDWARE AND REVISION SURGERY FOR A TOTAL HIP REPLACEMENT THE WEEK OF (B)(6) 2013, DATE UNKNOWN. THIS REPORT IS FOR AN UNKNOWN SPIRAL BLADE. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114060 HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention