BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSTONE VERTEBRAL BODY SPACER

    MDR report key: 1852332 · Received September 29, 2010

    Report

    Report Number
    1030489-2010-01265
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 1, 2010
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    MAX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG #2990822, 510K #K073291 WAS CLEARED IN THE UNITED STATES. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. PER THE REPORTER, THE REPORTED EVENT WAS NOT RELATED TO THE DEVICE. ALTHOUGH WE BELIEVE THAT NO DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS REPORT FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PLIF PROCEDURE AT L3-L5 USING INTERBODY DEVICE, THE IMPLANT FELL OFF ANTERIORLY AND INJURED THE VESSEL. THE PATIENT REPORTEDLY HAD A MASSIVE AMOUNT OF BLEEDING. THE PATIENT CURRENT STATUS IS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSTONE VERTEBRAL BODY SPACER CAGE MAX WARSAW ORTHOPEDIC INC. NA 004458W

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention