BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPLANT TAPERED 9X11X25MM

    MDR report key: 1918005 · Received December 3, 2010

    Report

    Report Number
    1530901-2010-00139
    Event Type
    Death
    Date Received
    December 3, 2010
    Date of Event
    November 8, 2010
    Report Date
    December 3, 2010
    Manufacturer
    THEKEN SPINE
    Product Code
    MQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS REPORT THE DEVICE INVOLVED WAS RETURNED TO MANUFACTURER AND IS BEING DECONTAMINATED FOR INVESTIGATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED BY REPRESENTATIVES FROM (B)(6) AND THE DISTRIBUTOR THAT A SPINAL SURGERY PROCEDURE FOR POSTERIOR LUMBAR INTERBODY FUSION (PLIF) AT DISC SPACE L4/L5, L5/S1 BEGAN AT 10.45AM USING A TA 9X11X25MM TI LPOD IMPLANT. AS THE ORTHOPEDIC SURGEON ADVANCED THE LEFT LPOD, HE SAW ON THE FLUOROSCOPY IMAGES THAT THE RIGHT LPOD WAS TOO FAR ANTERIOR AND THAT HE WANTED TO PULL THE CAGE BACK. BEFORE DOING THIS, HE ROTATED THE LEFT SIDE TO ENGAGE THE CAGE, REMOVED THE INSERTER, AND TOOK ANOTHER FLUOROSCOPY. THIS PICTURE SHOWED THAT THE RIGHT SIDE CAGE WAS APPROXIMATELY 5-8 MM MORE ANTERIOR THAN THE OTHER. ORTHOPEDIC SURGEON TRIED TO CONNECT THE CAGE TO THE INSERTER, HOWEVER, AFTER SEVERAL ATTEMPTS, THE CAGE/INSERTER CONNECTION WAS NOT STRONG ENOUGH TO PULL CAGE BACK. ORTHOPEDIC SURGEON TRIED TO PULL THE CAGE BACK BY USING A THIRD PARTY INSERTER (SYNTHES OR STRYKER) REMOVAL SET AND TRIED USING INSTRUMENTATION IN THE SURGICAL FIELD TO HOOK THE CAGE TO PULL BACK USING AN UP-ANGLE MICRO CURETTE AND A NERVE HOOK. AFTER SEVERAL ATTEMPTS, THERE WAS STILL NOT ENOUGH STRENGTH TO PULL BACK ON THE CAGE. A GENERAL SURGEON AT (B)(6) HOSPITAL WAS CONSULTED BY THE ORTHOPEDIC SURGEON, AND IT WAS DECIDED TO ATTEMPT TO REMOVE THE CAGE USING A NEW LATERAL SURGICAL APPROACH ON THE PT'S RIGHT SIDE. THERE WAS CONCERN REGARDING THE PROXIMITY OF THE IMPLANT TO THE ILIAC VEIN AND VENA CAVA. ACCORDING TO THE REPRESENTATIVES IN THE OPERATING ROOM, THE IMPLANT WAS REMOVED AT APPROXIMATE 2:10 P.M. HOWEVER, THERE WAS BLEEDING APPARENTLY FROM THE ILIAC VEIN AND/OR VENA CAVA THAT THE SURGEONS ATTEMPTED TO CONTROL. THE DISTRIBUTOR INFORMED INTEGRA AT APPROXIMATELY 4:40 P.M. THAT THE PT HAD DIED FROM BLEEDING COMPLICATIONS. ATTEMPTED REMOVAL OF THE IMPLANT POSTERIORLY ADDED ABOUT ONE HOUR TO THE SURGICAL TIME. INTEGRA REPRESENTATIVES MADE SEVERAL ATTEMPTS TO CONTACT THE HOSPITAL. ON NOVEMBER 15, 2010, (B)(6) REPRESENTATIVE SPOKE WITH OPERATING ROOM SUPERVISOR AT (B)(6) HOSPITAL TRYING TO OBTAIN ADDITIONAL CLINICAL INFO AND WAS INFORMED THE HOSPITAL COULD NOT ANSWER ANY QUESTIONS OR PROVIDE INFO REGARDING THIS EVENT. OPERATING ROOM SUPERVISOR CONFIRMED THE IMPLANTS WERE WITH THE PT AT THE CORONER EVALUATING THE CASE. (B)(6) REPRESENTATIVE SPOKE WITH THE DISTRIBUTOR ON NOVEMBER 15, 2010, WHO PROVIDED SIMILAR INFO PROVIDED AS THE (B)(6) REPRESENTATIVE. HE WAS NOT PRESENT WHEN THE PT DIED, HOWEVER, HE STATED THAT THERE IS NO INDICATION, IN HIS OPINION, THAT THERE WAS AN ISSUE WITH THE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANT TAPERED 9X11X25MM LPOD MQP THEKEN SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death| R