BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD INFINITY XR2 BASE UNIT

    MDR report key: 6987924 · Received October 30, 2017

    Report

    Report Number
    3004608878-2017-00302
    Event Type
    Injury
    Date Received
    October 30, 2017
    Date of Event
    October 17, 2017
    Report Date
    October 17, 2017
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    FWZ
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON NOVEMBER 21, 2017. FAILURE ANALYSIS: THE THREADED PIN WAS BROKEN OFF. DEVICE HISTORY REVIEW CAN NOT BE PERFORMED AT THIS TIME -- AS NO SERIAL NUMBER OR LOT# HAVE BEEN PROVIDED. CAPA HAS BEEN ISSUED TO FURTHER INVESTIGATE THIS REPORTED FAILURE AND AS SUCH A TREND ANALYSIS WILL BE CAPTURED IN THIS PROJECT. ROOT CAUSE: INTEGRA LIFE SCIENCES THOROUGHLY INVESTIGATED THE COMPLAINT EVENT. THIS INVESTIGATION INCLUDED OUTSOURCED MATERIAL TESTING, STRESS ENGINEERING AND FRACTOGRAPHY. THE CONSENSUS OF INVESTIGATION FINDS THE MOST LIKELY ROOT CAUSE OF COMPLAINT EVENT IS: USER APPLIED TORQUE TO KNOB IN EXCESS OF MATERIAL STRENGTH OF SCREW THREAD OR COMBINATION OF USER TORQUE AND CLAMP SUPPORT LOAD EXCEEDING SCREW THREAD STRENGTH.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE DOCTOR USED AN EVALUATION RADIOLUCENT SPINE TABLE ADAPTOR FOR A POSTERIOR CERVICAL DISCECTOMY AND INSTRUMENTATION FOR FUSION. ABOUT 10 DAYS BEFORE THE PROCEDURE, THE SALES REPRESENTATIVE INSPECTED THE RADIOLUCENT SPINE TABLE ADAPTOR AND NOTICED ITS PERFECT CONDITION, APPEARED TO BE A BRAND NEW PIECE OF EQUIPMENT. COMPONENTS WERE CHECK FOR STABLE AND SECURE CONNECTIONS. BEFORE THE CASE BEGAN ON (B)(6) 2017, SALES REPRESENTATIVE RECHECKED THE COMPONENTS BEFORE SURGERY. THE RADIOLUCENT SPINE TABLE ADAPTOR WAS SCREWED INTO BOTH SIDES OF THE RADIOLUCENT SKULL CLAMP AND A PERFECT/FLUSH CONNECTION BETWEEN THE STARBURST ON THE SWIVEL ADAPTOR AND THE TWO STARBURSTS ON THE SKULL CLAMP WAS NOTICED. THE SALES REPRESENTATIVE ASSISTED THE NURSE WITH ADJUSTING THE SYSTEM ON THE JACKSON TABLE. ONCE THE MALE PATIENT WAS POSITIONED ON THE SPINE TABLE, SALES REPRESENTATIVE CONFIRMED THAT ALL CONNECTIONS THAT THE NURSE HAD TIGHTENED WERE STABLE AND READY FOR THE PROCEDURE. THE STAFF AND THE SURGEON TAPPED THE PATIENT INTO THE DESIRED POSITION ON THE TABLE TO FURTHER ENSURE THAT THE PATIENT WOULD NOT MOVE DURING PROCEDURE. THE CASE STARTED AND THE DRAPING BEGIN. THE SALES REPRESENTATIVE HAD LEFT THE OPERATING ROOM SUITE. ABOUT 35-40 MINUTES LATER, THE CIRCULATOR, TECHS, AND OTHER REPRESENTATIVE HELPING IN THE CASE REPORTED TO THE SALES REPRESENTATIVE WHO WAS NOT PRESENT AT THE TIME OF THE INCIDENT THAT THE PATIENT WASN¿T MOVING HIS LIMBS UPON THE ANESTHETIST¿S COMMANDS. AT THE TIME OF WHEN THE INCIDENT OCCURRED, THE DOCTOR HAD DISSECTED TO THE POINT WHERE HE WAS GETTING READY TO DECOMPRESS THE DISC SPACE AND PLACE HIS SCREWS. THE SALES REPRESENTATIVE WAS NOT CERTAIN IF THE DOCTOR WAS OPERATING OR APPLYING PRESSURE TO THE PATIENT, BUT SUPPOSEDLY THERE WAS A FAINT ¿SNAP¿ SOUND AND THE PATIENT'S HEAD AND NECK SHIFTED TOWARDS THE FLOOR VERY ABRUPTLY. THE PHYSICIAN¿S ASSISTANT QUICKLY DROPPED BELOW THE BED AND DRAPES TO SUPPORT THE PATIENT¿S HEAD AND NECK UNTIL OTHERS COULD HELP. THE DOCTOR THEN DID A PARTIAL CLOSURE. THE SALES REPRESENTATIVE THEN JUST SAW THE PATIENT IN THE TRANSPORT BED WHILE THE STAFF WORKED TO WAKE THE PATIENT UP. THE PATIENT WASN¿T MOVING HIS EXTREMITIES ON COMMAND. THE SALES REPRESENTATIVE WAS NOT CERTAIN HOW THE PATIENT IS DOING TODAY. A DELAY OF 1.5 HOURS WAS REPORTED DUE TO THE PRODUCT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767909 MAYFIELD INFINITY XR2 BASE UNIT MAYFIELD FWZ INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R JACKSON TABLE| RADIOLUCENT SKULL CLAMP| RADIOLUCENT SPINE TABLE ADAPTOR