BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 9682250 · Received February 7, 2020

    Report

    Report Number
    1030489-2020-00152
    Event Type
    Injury
    Date Received
    February 7, 2020
    Report Date
    February 7, 2020
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    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 # 8115525, 510K # K030840 AND 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 PERCUTANEOUS PEDICLE SCREW PLACEMENT AT L2-L3, CROSSLINK PLACEMENT WAS PERFORMED AT S1, SCREW INSERTION WAS PERFORMED AT S2AI AND RODS WERE INSERTED ON BOTH SIDES. ON AN UNKNOWN DATE, POST-OP, THE LEFT SIDE OF THE CROSSLINK AT S1-S2AI DEVIATED (BACKED-OUT) FROM SACRUM. ALONG WITH THE ALLEGED CROSSLINK, TWO PEDICLE SCREWS BACKED-OUT ON THE RIGHT SIDE OF S1. HENCE, A REVISION SURGERY, WAS PERFORMED, IN WHICH, THE BACKED-OUT CROSSLINK WAS EXPLANTED AND WAS REPLACED WITH A NEW ONE. THE BACKED-OUT SCREWS WERE REMOVED; AND WERE REPLACED WITH SCREWS OF BIGGER SIZE, WITH CHANGE IN INSERTION ANGLE. ROD PLACEMENT WAS PERFORMED AGAIN. ADDITIONAL CROSSLINK PLACEMENT WAS PERFORMED BETWEEN L2-L3. THE PROCEDURE WAS THEN COMPLETED. THERE WAS A DELAY OF MORE THAN 60 MINUTES IN OVERALL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146575 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0291917W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention