BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSTONE SPINAL SYSTEM

    MDR report key: 4182008 · Received October 10, 2014

    Report

    Report Number
    MW5038624
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    February 13, 2008
    Report Date
    October 10, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    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, MEDTRONIC CONSULTANT DR. (B)(6) IMPLANTED THERAPEUTIC BIOLOGIC BONE MORPHOGENETIC PROTEIN IN COMBINATION WITH INTERBODY CAGE(S) INTO PATIENT WITH CD HORIZON SUPPLEMENTAL FIXATION AT (B)(6) HOSPITAL IN (B)(6). THE BIOLOGIC IS DISTRIBUTED UNDER TRADE NAME CAPSTONE SPINE SYSTEM (SIZES WERE 26 X 12MM AND 26 X 8MM). THE COMBINATION OF INFUSE AND CAPSTONE CAGES REQUIRED PMA UNDER 21 CFR 888.3080. NO PMA WAS OBTAINED PRIOR TO COMMERCIAL DISTRIBUTION. THE CAPSTONE DEVICES WERE DISTRIBUTED INTO COMMERCE AND IMPLANTED INTO PATIENT NEARLY 7 WEEKS PRIOR TO RECEIVING FINAL CLEARANCE ORDER ON (B)(6) 2008 UNDER K073291. PATIENT DEVELOPED POST-OPERATIVE COMPLICATIONS, INCLUDING BUT NOT LIMITED TO WORSENING OF PRE-OPERATIVE SYMPTOMS, BMP-INDUCED ECTOPIC BONE GROWTH AND A CYST NEAR THE IMPLANT SITE. REVISION SURGERY WAS CONDUCTED ON (B)(6) 2010 TO EXPLANT SUPPLEMENTAL FIXATION DEVICES, DEBRIDE THE CYST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637795 CAPSTONE SPINAL SYSTEM INTERVERTEBRAL BODY FUSION CAGE 26 X 12MM MAX MEDTRONIC SOFAMOR DANEK 2991226
    637796 INFUSE BONE GRAFT BONE MORPHOGENETIC PROTEIN NEK MEDTRONIC SOFAMOR DANEK
    637797 CD HORIZON SUPPLEMENTAL FIXATION SUPPLEMENTAL FIXATION NKB MEDTRONIC SOFAMOR DANEK * *
    637811 CAPSTONE SPINAL SYSTEM INTERVERTEBRAL BODY FUSION CAGE 26 X 8MM MAX MEDTRONIC SOFAMOR DANEK * *

    Patients

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