BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD TRIAD SKULL CLAMP

    MDR report key: 1211297 · Received October 21, 2008

    Report

    Report Number
    3004608878-2008-00089
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Report Date
    October 21, 2008
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE USER FACILITY REPORTS A PT INJURY-LACERATION. THEY FURTHER REPORT, THEY SUSPECT USER ERROR, BUT SENDING THE UNIT IN TO BE SURE IT IS OK TO USE. ADDITIONAL INFO: NEURO TEAM LEADER REPORTS VIA E-MAIL THAT WHEN THE SKULL CLAMP WAS REMOVED, AFTER A POSTERIOR CERVICAL FUSION, A SKIN TEAR WAS FOUND ON THE LEFT SIDE OF THE HEAD. A RESIDENT SURGEON PLACED 3 STAPLES TO REPAIR THE 1 CM LACERATION. SHE FURTHER REPORTS THAT THERE WERE NO OTHER PT RELATED ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD TRIAD SKULL CLAMP MAYFIELD CLAMP HBL INTEGRA LIFESCIENCES CORPORATION 044

    Patients

    Seq Age Sex Outcome Treatment
    1