BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PITUITARY RONGUER

    MDR report key: 329317 · Received April 27, 2001

    Report

    Report Number
    1423507-2001-00128
    Event Type
    Injury
    Date Received
    April 27, 2001
    Date of Event
    September 28, 1998
    Report Date
    April 27, 2001
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP.
    Product Code
    EMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IN 1998, THE PLAINTIFF UNDERWENT A LUMBAR LAMINECTOMY. THE PLAINTIFF ALLEGES THAT THE PITUITARY RONGEUR BROKE APART, CAUSING METAL FRAGMENTS OF THE INSTRUMENT TO DISPERSE IN THE OPERATIVE FIELD. THE PLAINITFF FURTHER ALLEGES THAT THE DEFENDANT DID NOT REMOVE ALL OF THE METALLIC FRAGMENTS FROM THE PLAINTIFF'S BACK. AS A RESULT, THE PLAINTIFF ALLEGES THEY HAVE SUFFERED INJURY TO THEIR SPINE, ITS MUSCLES, NERVES, DISCS, AND BONES, WEAKNESS AND PARATHESIS OF ALL MUSCLE GROUPS IN THEIR LOW BACK AND LOWER EXTREMITIES, SENSORY IMPAIRMENT OF BOTH EXTREMITIES, WEAKNESS AND PARATHESIS IN THEIR LOWER LEFT EXTREMITY, SEVERE AND DISABLING LOW BACK PAIN, SEVERE EMOTIONAL AND PSYCHOLOGICAL SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19457 PITUITARY RONGUER PITUITARY RONGEUR EMH ALLEGIANCE HEALTHCARE CORP. UNK-RONGEUR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other