BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 8901572 · Received August 16, 2019

    Report

    Report Number
    1030489-2019-00904
    Event Type
    Injury
    Date Received
    August 16, 2019
    Date of Event
    July 17, 2019
    Report Date
    August 16, 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 # 1606200500, 510K # K131321; 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 OBLIQUE LATERAL INTERBODY FUSION (OLIF) OF 4 INTERVERTEBRAL DISCS, WHICH IS IN BETWEEN L1-L5, POSTERIOR LUMBAR INTERBODY FUSION (PLIF) AT L5/S AND POSTERIOR FIXATION FROM T9 TO S2AI DUE TO DEGENERATIVE SCOLIOSIS. POST-OP, RODS BREAKAGE OCCURRED ON BOTH SIDES OF L5/S. DUE TO THIS REVISION SURGERY WAS PERFORMED ON (B)(6) 2019. PATIENT COMPLICATIONS WERE UNKNOWN AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695559 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention