BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHX INFLATABLE BONE TAMP

    MDR report key: 1846198 · Received September 24, 2010

    Report

    Report Number
    2953769-2010-00526
    Event Type
    Injury
    Date Received
    September 24, 2010
    Date of Event
    August 24, 2005
    Report Date
    August 24, 2005
    Manufacturer
    MEDTRONIC SPINE LLC
    Product Code
    HRX
    PMA / PMN Number
    K981251
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED; FOLLOWED UP WITH COMPANY REP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A BALLOON KYPHOPLASTY PROCEDURE AT LEVEL T4. WHILE GAINING ACCESS TO THE VERTEBRAL BODY, AN ACCESS NEEDLE WAS INADVERTENTLY DIRECTED TOO FAR MEDIALLY, ENTERED THE SPINAL CANAL AND PUNCTURED THE SPINAL CORD. THE PHYSICIAN, UPON SEEING SPINAL FLUID, WITHDREW THE NEEDLE AND REDIRECTED IT. IT WAS NOTED THAT BONE CEMENT DID NOT EXTRAVASATE OUT OF THE VERTEBRAL BODY. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATION. POST PROCEDURE, IN THE RECOVERY ROOM, THE PT NOTED MUSCLE WEAKNESS IN HER LEFT LEG WHILE SENSATION REMAINED INTACT. REPORTEDLY, THE PT REGAINED SOME MUSCLE STRENGTH; HOWEVER, FULL RECOVERY IS NOT EXPECTED. NO ADDITIONAL INFO WAS REPORTED. NOTE: THE ACCESS NEEDLE USED IN THIS PROCEDURE WAS NOT SOLD OR DISTRIBUTED BY MEDTRONIC SPINE LLC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHX INFLATABLE BONE TAMP INFLATABLE BONE TAMP HRX MEDTRONIC SPINE LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Disability