BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 1565521 · Received December 8, 2009

    Report

    Report Number
    3004608878-2009-00097
    Event Type
    Other
    Date Received
    December 8, 2009
    Date of Event
    November 4, 2009
    Report Date
    December 8, 2009
    Manufacturer
    INTEGRA-OHIO
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    A MAYFIELD SKULL CLAMP WAS INVOLVED IN A SLIPPAGE AND PT INJURY DURING A PROCEDURE. THE RPTR DESCRIBED THE EVENT AS: ON (B)(6) 2009, A (B)(6) FEMALE PT WAS PREPARED FOR A STEREOTACTIC BRAIN BIOPSY WITH A STELF. DURING SURGERY IT WAS NOTED THAT THE NAVIGATION SYSTEM (STELF) DID NOT MATCH THE PT. THE PT WAS CHECKED AND IT WAS FOUND THAT THE PT HAD MOVED AND HAD INCURRED A 1/2" SCALP LACERATION. THE LACERATION WAS LOCATED ON THE LEFT TEMPORAL SIDE OF THE PT'S SCALP AND REQUIRED STAPLES TO CLOSE THE WOUND. THE PT RECOVERED. SURGERY WAS DELAYED FOR APPROX 15 MINS. MAYFIELD ADULT DISPOSABLE PINS (A1083) WERE BEING USED AT THE TIME. THE BASE UNIT A2101 (B)(4) AND HEADREST (B)(4) WERE ALSO USED DURING THIS PROCEDURE. THE INTEGRA LIFE SCIENCE REPRESENTATIVE HAS BEEN INSTRUCTED TO PROVIDE AN IN-SERVICE PROGRAM FOR THE STAFF ABOUT HOW TO PROPERLY APPLY THE SKULL CLAMP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other