BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLM INTRACRANIAL PRESSURE

    MDR report key: 790611 · Received November 22, 2006

    Report

    Report Number
    2023988-2006-00053
    Event Type
    Malfunction
    Date Received
    November 22, 2006
    Date of Event
    September 8, 2006
    Report Date
    November 20, 2006
    Manufacturer
    INTEGRA NEUROSCIENCES
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURN IS AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    ON 10/31/06, INTEGRA LIFESCIENCES CORP RECEIVED A VOLUNTARY MEDWATCH REPORTING THE FOLLOWING EVENT: A FEMALE PT WITH A BRAIN TUMOR IN THE LEFT FRONTAL CRANIAL LOBE UNDERWENT A SURGICAL PROCEDURE. WHILE THE PHYSICIAN WAS SCREWING AN ICP BOLT INTO THE PT'S SKULL, THE BOLT BROKE. THE OPERATING STAFF REPORTED THAT THE INSERTION WAS NORMAL WITH NO INDICATION OF OBSTRUCTION OR PROBLEMS PRIOR TO THE BREAKAGE. RISK MANAGEMENT REP AT THE USER FACILITY PROVIDED THE FOLLOWING ADD'L INFO: THE PT IS VERY ILL AND HAD AN EXTREMELY COMPLICATED RECOVERY POST REMOVAL OF A BRAIN TUMOR. DESPITE ALL THE COMPLICATIONS, SHE IS RECOVERING AND HER PROGNOSIS IS BELIEVED TO BE FAIRLY GOOD. THE BREAKAGE OCCURRED APPROX 2 MILLIMETERS FROM WHERE THE ACTUAL SCREW MEETS THE BASE OF THE BOLT. IT IS UNK WHETHER OR NOT ANOTHER DEVICE WAS BEING USED TO ASSIST IN THE APPLICATION OF THE BOLT. NO PLANS HAVE BEEN MADE TO REMOVE THE SECTION OF BOLT REMAINING IN THE PT'S SKULL. ACCORDING TO THE PHYSICIANS, THERE WAS NO INJURY TO THE PT, AND NONE OF THE HEALTH COMPLICATIONS THAT SHE SUSTAINED POST SURGERY WERE CONTRIBUTED TO THE FRACTURE OF THE DEVICE. AT THIS JUNCTION IT IS NOT BELIEVED THAT THE BOLT WILL POSE ANY HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLM INTRACRANIAL PRESSURE ICP DISPOSABLES GWM INTEGRA NEUROSCIENCES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR