BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD SKULL CLAMP

    MDR report key: 1000645 · Received February 15, 2008

    Report

    Report Number
    3004608878-2008-00007
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Report Date
    February 15, 2008
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HBL
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INCIDENT. CORRESPONDENCE SHOULD BE SENT TO: INTEGRA LIFESCIENCES CORPORATION, 311 ENTERPRISE DRIVE, PLAINSBORO, NJ 08536, ATTN: CORPORATE COMPLAINT COORDINATOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE'S PRESSURE SCREW CANNOT BE MOVED; RESULTING IN THE INABILITY OF THE HOSPITAL STAFF TO REMOVE A PT FROM THE DEVICE AFTER AN OPERATION. TUBING PLIERS HAD TO BE USED TO TURN THE SCREW. THE CLAMP IS NOT USED VERY OFTEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD SKULL CLAMP SKULL CLAMP HBL INTEGRA LIFESCIENCES CORPORATION 57

    Patients

    Seq Age Sex Outcome Treatment
    1