BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 2214107 · Received July 20, 2011

    Report

    Report Number
    3004608878-2011-00100
    Event Type
    Other
    Date Received
    July 20, 2011
    Date of Event
    July 10, 2011
    Report Date
    July 20, 2011
    Manufacturer
    INTEGRA, CINCINNATI
    Product Code
    HBL
    Adverse Event
    Yes
    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 EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    A MAYFIELD SKULL CLAMP (A1059) WAS PLACED ON THE PTS' HEAD AND THEN THE PT WAS POSITIONED PRONE ON THE OPERATING ROOM TABLE WHEN THE CLAMP SLIPPED. THE PT INCURRED A 6CM LACERATION TO THE LEFT SIDE OF THE SCALP. THE PT WAS RETURNED TO A STRETCHER WHERE THE LACERATION WAS SUTURED. ANOTHER SKULL CLAMP WAS APPLIED AND THE CASE CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD MODIFIED SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA, CINCINNATI 091

    Patients

    Seq Age Sex Outcome Treatment
    1