BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 1060037 · Received June 11, 2008

    Report

    Report Number
    3004608878-2008-00033
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Report Date
    June 11, 2008
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE DEVICE "WOBBLED ON THE PT'S HEAD." RECEIVED ADD'L INFO IN 2008 FROM THE O.R. COORDINATOR. HE ADVISED THAT THERE WAS NO INJURY TO THE PT BUT IF THE DEVICE HAD BEEN USED, THERE WOULD HAVE BEEN A PROBLEM. HE FURTHER STATED THAT THE RESIDENT WAS HANDLING THE DEVICE, AND IT WAS WOBBLING PRIOR TO BEING USED ON THE PT. THIS DEVICE DID NOT COME INTO CONTACT WITH THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD MODIFIED SKULL CLAMP NONE HBL INTEGRA LIFESCIENCES CORPORATION 051

    Patients

    Seq Age Sex Outcome Treatment
    1