BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSTONE CAGE

    MDR report key: 5249609 · Received November 19, 2015

    Report

    Report Number
    MW5058083
    Event Type
    Injury
    Date Received
    November 19, 2015
    Date of Event
    February 13, 2008
    Report Date
    November 19, 2015
    Manufacturer
    MEDTRONIC
    Product Code
    MAX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2008, PT UNDERWENT 3-LEVEL PLIF INVOLVING THREE LARGE INFUSE BONE GRAFT KITS (PMA 000058) USED IN COMBINATION WITH THREE CAPSTONE SPACERS (K073291). THE COMBINATION OF PRODUCTS WAS NON-FDA APPROVED, THE CAPSTONE SPACERS WERE NOT FDA-CLEARED UNTIL APRIL 24, 2008. THEREFORE THERE WAS NO 510(K) CLEARANCE IN EFFECT WHEN THE CAPSTONE INTERBODY CAGES WERE IMPLANTED INTO THE PT. THERE WAS NO INVESTIGATIONAL DEVICE EXEMPTION ON (IDE), NO INSTITUTIONAL REVIEW BOARD (IRB) APPROVAL AND PT WAS NOT INFORMED THAT THE CAPSTONE DEVICE WAS NON-FDA APPROVED OR CLEARED. PT DEVELOPED BMP-INDUCED BONY OVERGROWTH THAT ESCAPED FROM THE CAPSTONE DEVICES, LEADING TO COMPRESSION OF SURROUNDING NEUROLOGICAL STRUCTURES, RENDERING THE PT FULLY DISABLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766201 CAPSTONE CAGE CAPSTONE CAGE MAX MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| O| S