BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SOLERA SPINAL SYSTEM

    MDR report key: 9080368 · Received September 18, 2019

    Report

    Report Number
    1030489-2019-01031
    Event Type
    Malfunction
    Date Received
    September 18, 2019
    Date of Event
    July 17, 2019
    Report Date
    September 18, 2019
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 6430530, 510K # K143375, UDI# (B)(4) WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR ANTERIOR AND POSTERIOR INTERBODY FUSION AT L5-S1 AND OBLIQUE LATERAL INTERBODY FUSION AT L3/4 ,L4/5 DUE TO SPINAL CANAL STENOSIS. INTRA-OP, STRIPPING HAPPENED WHEN SET SCREW WAS INSERTED IN THE SCREW OF AT S1. SET SCREW WAS REPLACED WITH OTHER SET SCREW AND FINAL TIGHTENING WAS DONE SUCCESSFULLY. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874192 CD HORIZON SOLERA SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0676568W

    Patients

    Seq Age Sex Outcome Treatment
    1