BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2082433 · Received May 10, 2011

    Report

    Report Number
    1030489-2011-00531
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 15, 2011
    Report Date
    August 2, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 8670855, 510K # K000453 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.

    Additional Manufacturer Narrative · 1

    THE SCREW WAS RETURNED FOR ANALYSIS. MACROSCOPIC AND OPTICAL EXAMINATION REVEALED THREAD CREST AND FLANK DAMAGE; THIS DAMAGE APPEARS TO HAVE INITIATED AT THE START OF THE THREAD, AND IS NOTED ON BOTH RETURNED SET SCREWS AND MAS, CONSISTENT WITH SET SCREW MISALIGNMENT OF THE MAS HEAD AND SET SCREW THREADS DURING CONSTRUCT ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER A MINI-INVASIVE SPINAL PROCEDURE CHANGE TO OPEN PROCEDURE, THE BREAK OFF SET SCREW COULD NOT BE BROKEN OFF. THE PEDICLE SCREW FINALLY WAS REPLACED. THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER INCIDENT. BOTH REPLACED SET SCREWS AND PEDICLE SCREW WERE CHECKED AFTER THE SURGERY. THEY ARE DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM KWP WARSAW ORTHOPEDIC, INC. NA 0131833W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PEDICLE SCREWS