BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 9523096 · Received December 27, 2019

    Report

    Report Number
    1030489-2019-01493
    Event Type
    Malfunction
    Date Received
    December 27, 2019
    Report Date
    December 27, 2019
    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 # 8699100, 510K # K981676 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 PRESENTED WITH LUMBAR SPINAL CANAL STENOSIS; AND UNDERWENT POSTERIOR SPINAL FUSION (PSF) AT L4-S2AI AND TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT L5-S1. ON AN UNKNOWN DATE, POST-OP, THE TITANIUM RODS THAT HAD BEEN IMPLANTED WERE BENT AND THE CAGE BACKED OUT. THE BACKED-OUT CAGE WAS T-PAL, MANUFACTURED BY DEPUY SYNTHES. DUE TO THE REPORTED EVENT, A REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2019 TO REPLACE THE RODS, TO INCREASE THE RIGIDITY OF THE RODS AND TO INSERT THE CAGE AGAIN. IT IS UNKNOWN IF THIS REVISION SURGERY HAS BEEN PERFORMED OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322221 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0553059W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention