BEUDAMED
    FDA Adverse Event Other Summary report: N

    HFD100 SKULL CLAMP ASSEMBLY

    MDR report key: 2483576 · Received February 27, 2012

    Report

    Report Number
    3003807210-2012-00001
    Event Type
    Other
    Date Received
    February 27, 2012
    Date of Event
    January 6, 2012
    Report Date
    February 24, 2012
    Manufacturer
    IMRIS, INC.
    Product Code
    HBL
    PMA / PMN Number
    K103493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CHARGE NURSE AT AN IMRIS CUSTOMER SITE REPORTED SLIPPAGE OF AN IMRIS HEAD FIXATION DEVICE (HFD100) DURING A SURGICAL PROCEDURE. INJURY (LACERATION) WAS REPORTED AND SUTURES WERE REQUIRED. THE CUSTOMER NOTED SOME ROTARY MOVEMENT OF THE ROCKER ARM FOLLOWING LOCKING PROCEDURES FOR THE HFD100 SKULL CLAMP ASSEMBLY DURING THE SURGERY AND PROCEEDED WITH THE SURGERY. THE ROTATIONAL MOVEMENT CANNOT BE DIRECTLY TIED TOT HE REPORTED INJURY. INCORRECT PINNING TECHNIQUE IS ONE POSSIBLE CAUSE OF THIS INJURY; HOWEVER DATA IS NOT AVAILABLE TO ASSESS THE SPECIFIC APPLICATION OF THE SKULL CLAMP TO THIS PATIENT. THE ROTATIONAL MOVEMENT (APPROXIMATELY 1/8 INCH) OBSERVED ON THE ROCKER ARM SIDE OF THE HFD100 SKULL CLAMP ASSEMBLY IS A MANUFACTURING AND/OR DESIGN RELATED ISSUE AND FURTHER INVESTIGATION IS REQUIRED TO IDENTIFY THE EXACT CAUSE AND CORRECTIVE ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HFD100 SKULL CLAMP ASSEMBLY NEUROSURGICAL HEAD HOLDER (SKULL CLAMP) HBL IMRIS, INC. 112229-000

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other