BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHX 11 GAUGE BONE ACCESS NEEDLE

    MDR report key: 485911 · Received September 26, 2003

    Report

    Report Number
    2953769-2003-00010
    Event Type
    Injury
    Date Received
    September 26, 2003
    Date of Event
    August 28, 2003
    Report Date
    August 28, 2003
    Manufacturer
    KYPHON INC.
    Product Code
    GCB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SEVERAL ATTEMPTS HAVE BEEN MADE TO CONTACT TREATING SURGEON. THE FOLLOWING INFORMATION IS BASED ON LIMITED INFORMATION RECEIVED. A PATIENT TREATED FOR THREE VERTEBRAL BODY COMPRESSION FRACTURES IN THE THORACIC SPINE UNDERWENT SURGERY WITHOUT APPARENT DIFFICULTY. HOWEVER, AFTER RECOVERY, THE PATIENT WAS UNABLE TO MOVE THEIR LEGS. A CT REPORTEDLY REVEALED SOME BONE FROM THE PEDICLE IN THE CANAL. A DECOMPRESSION AND EXPLORATORY SURGERY WAS PERFORMED. THE CORD WAS FOUND TO BE INTACT, NO BONE CEMENT SEEN IN THE CANAL, BUT THERE WAS A HEMATOMA IN THE EPIDURAL OR SUBDURAL SPACE. THE DURA WAS REPAIRED AND THE HEMATOMA REMOVED. THREE HOURS POST OP THE PATIENT'S PARAPLEGIA PERSISTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHX 11 GAUGE BONE ACCESS NEEDLE BONE ACCESS NEEDLE GCB KYPHON INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention