BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLORADO 2 SPINAL SYSTEM

    MDR report key: 1556389 · Received December 4, 2009

    Report

    Report Number
    1030489-2009-01145
    Event Type
    Malfunction
    Date Received
    December 4, 2009
    Date of Event
    November 12, 2009
    Report Date
    November 12, 2009
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    MNH
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    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 # 8630645, 510K # K991031 WAS CLEARED IN THE UNITED STATES. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 PEDICLE SCREW WAS BROKEN DURING INSERTION AT A SPINAL SURGICAL PROCEDURE AT L4-L5. THE BROKEN SCREW WAS NOT REMOVED. NO OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLORADO 2 SPINAL SYSTEM BONE SCREW MNH WARSAW ORTHOPEDIC INC. NA 0019885W

    Patients

    Seq Age Sex Outcome Treatment
    1