BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R90 SPACERS

    MDR report key: 1513913 · Received October 9, 2009

    Report

    Report Number
    1030489-2009-00927
    Event Type
    Malfunction
    Date Received
    October 9, 2009
    Report Date
    September 11, 2009
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    MQP
    PMA / PMN Number
    NA
    Product Problem
    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# 29405145S, 510K# K033926 WAS CLEARED IN THE UNITED STATES. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVAL. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WHO HAD STENOSIS UNDERWENT PLIF AT L4/5 TO IMPLANT INTERBODY SPACER. IT WAS REPORTED THAT ONE OF THE IMPLANTED DEVICES BACKED OUT POST OP. THE PT COMPLAINED OF PAIN. THE SURGEON COMMENTED THAT SIZE OF THE DEVICE THAT HE CHOSE FOR THIS PT MAY HAVE BEEN TOO SMALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 R90 SPACERS VB SPACER MQP WARSAW ORTHOPEDIC INC. NA 0000699W

    Patients

    Seq Age Sex Outcome Treatment
    1