BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 1553708 · Received December 3, 2009

    Report

    Report Number
    3004608878-2009-00095
    Event Type
    Other
    Date Received
    December 3, 2009
    Report Date
    December 3, 2009
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    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. INTEGRA-LIFE SCIENCES NEURO ENGINEERS DID A THOROUGH EVALUATION ON THE RETURNED UNIT AND FOUND THE FOLLOWING; THE UNIT OPERATES NORMALLY DURING FUNCTIONAL TESTING: 80# TORQUE KNOB TESTED GOOD UNDER PRESSURE; RATCHET EXTENSION ARM HAS NO VISIBLE CRACKS; LOCK HAS A LITTLE ROTATIONAL MOVEMENT WHICH WOULD NOT HAVE CAUSED A SLIPPAGE. THE LARGE STARBURST TEETH SHOW SOME WEAR BUT ARE STILL FUNCTIONAL AND WOULD NOT HAVE CAUSED A SLIPPAGE. THE ROCKER ARM PASSES GO NOGO GAGE; ALL OTHER COMPONENTS ARE FUNCTIONAL. THE ENGINEERS WERE UNABLE TO DUPLICATE OR CONFIRM THE REASON FOR THE SLIPPAGE. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    THIS IS THE THIRD REPORT OF SLIPPAGE AND OR INJURY FROM THE SAME FACILITY. (B)(4). A MAYFIELD SKULL CLAMP (LOT #031) WAS INVOLVED IN A LACERATION DURING A PT PROCEDURE. THE REPORTER DESCRIBED THE EVENT AS; 80# TORQUE KNOB FAILED AND CAUSED A LACERATION ON THE PT. ADDITIONAL CLINICAL INFO HAS BEEN REQUESTED. THE INTEGRA-LIFE SCIENCES SALES REPRESENTATIVE WILL PROVIDE AN IN-SERVICE PROGRAM AND OR ANSWER IN-SITU QUESTIONS FOR THE STAFF ON HOW TO APPROPRIATELY APPLY THE CLAMP TO PREVENT FURTHER SLIPPAGE AND INJURY. THE FACILITY SEEMS TO BE OPEN TO THIS PROPOSED ARRANGEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1