BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 7054939 · Received November 22, 2017

    Report

    Report Number
    3004608878-2017-00317
    Event Type
    Malfunction
    Date Received
    November 22, 2017
    Date of Event
    November 1, 2017
    Report Date
    November 6, 2017
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    PMA / PMN Number
    PRE-AMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON NOVEMBER 17, 2017. FAILURE ANALYSIS: COMPLAINT NOT CONFIRMED - NO ISSUES OBSERVED. UNIT CLEANED PER PROTOCOL (B)(4). WITH RESPECT TO THE RETURNED UNIT, IT HAS PASSED ALL SPECIFIC FUNCTIONAL TESTING REQUIREMENTS WHEN INSPECTED PER THE (B)(4). WHEN THE UNIT IS PROPERLY POSITIONED AND PUT UNDER PRESSURE, IT DID NOT SLIP. DEVICE HISTORY RECORD REVIEWED FOR SN (B)(4) /2001041 LOT/ 17 A TOTAL OF (B)(4) PIECES WERE MANUFACTURED ON 3/23/2017 SHOW NO ABNORMALITIES RELATED TO THE REPORTED FAILURE. THE DEVICES MANUFACTURED DURING THIS PERIOD PASSED ALL REQUIRED INSPECTION POINTS EXCEPT FOR REJECTED PRODUCT LABELS WHICH WERE REPLACED. 100% OF THIS PRODUCT IS INSPECTED PER INSPECTION REQUIREMENTS PRIOR TO LEAVING INTEGRA FACILITY. THE SAMPLING PLAN HAS BEEN REVIEWED AND DETERMINED TO BE COMMENSURATE TO THE APPROPRIATENESS AND ACCURACY TO CURRENT COMPLAINT NEEDS. NO MANUFACTURING OR DESIGN RELATED TREND HAS BEEN IDENTIFIED. POST MARKET INFORMATION WILL CONTINUE TO BE MONITORED. ROOT CAUSE ANALYSIS IS UNDETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE MAYFIELD MODIFIED SKULL CLAMP SLIPPED IN THE MIDDLE OF THE CASE. IT IS UNCERTAIN AS TO WHETHER IT WAS THE BASE UNIT OR THE C-CLAMP. THE DATE OF THE INCIDENT WAS REPORTED AS (B)(6) 2017, FOR A (B)(6)-YEAR-OLD MALE. THERE WAS NO PATIENT INJURY OR DEATH ALLEGED. NO REVISION/MEDICAL INTERVENTION REQUIRED. THERE WAS NO DELAY IN SURGERY. ADDITIONAL REQUEST FOR INFORMATION WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831972 MAYFIELD MODIFIED SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR