BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEBRAL AUGMENTATION ACCESS KIT

    MDR report key: 3533980 · Received December 23, 2013

    Report

    Report Number
    2520274-2013-07940
    Event Type
    Malfunction
    Date Received
    December 23, 2013
    Date of Event
    November 27, 2013
    Report Date
    November 27, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    KIH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FZX, HTW, HXG: ADDITIONAL CODES. 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. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VERTEBRAL BODY PROCEDURE ON THE RIGHT SIDE OF THE PATIENT, THE SURGEON WAS DOING BILATERAL BALLOON INFLATION AT THE SAME TIME. WHILE APPLYING PRESSURE WITH THE INFLATION SYSTEM, THE TIP OF THE MEDIUM SIZED BALLOON ON THE RIGHT SIDE (CLOSEST TO THE INFLATION SYSTEM) WAS LEAKING WATER AND CONTRAST DYE SOLUTION. THE SURGEON USED ANOTHER BALLOON AVAILABLE TO COMPLETE THE PROCEDURE. PART OF THE SCREWS HAD BROKEN LOOSE. ALL BROKEN FRAGMENTS WERE RETRIEVED EASILY WITHOUT ADDITIONAL MEDICAL INTERVENTION. THERE WAS A FIVE MINUTE DELAY IN COMPLETING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PATIENT. THIS COMPLAINT IS ON THE VERTEBRAL ACCESS KIT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673006 VERTEBRAL AUGMENTATION ACCESS KIT KIH SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR