BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-03291

    MDR report key: 3163408 · Received June 11, 2013

    Report

    Report Number
    2520274-2013-03291
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    June 25, 2012
    Report Date
    May 14, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    KIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS CANNOT BE DETERMINED WITHOUT A PART NUMBER INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THE REPLACEMENT OF A HOOK. THE SURGEON REPLACED THE PROXIMAL HOOK OF HYBRID TYPE FROM THE RIGHT FOURTH RIB TO THE SECOND LUMBAR VERTEBRA TO ONE FROM THE FOURTH RIB TO THE FIFTH RIB. ONE BLUE CLIP AND TWO GOLD ONES WERE USED. FROM THE DOCTOR'S POINT OF VIEW THIS PROBLEM WAS ROTATION OUT OF THE HOOK. THERE IS NOT A DEFECT AND HEALTH HAZARD IN THIS SURGERY. THE DOCTOR CAN¿T IDENTIFY THE REASON DUE TO SHAKEOUT OF THE RIB, HE THINKS THIS ISSUE INVOLVED FLACCIDNESS OF THE PATIENT¿S BONE. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264686 KIK SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention