BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 9478905 · Received December 17, 2019

    Report

    Report Number
    1030489-2019-01427
    Event Type
    Malfunction
    Date Received
    December 17, 2019
    Date of Event
    November 18, 2019
    Report Date
    December 17, 2019
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    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 # 55840005535, 510K # K113174, 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 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT L2/3 DUE TO OSSIFICATION OF THE YELLOW LIGAMENT (OYL). INTRA-OP, THE PEDICLE SCREW (PS) ON THE LEFT SIDE OF L2 DEVIATED TO THE LATERAL SIDE. WHEN THE REINSERTION OF PS WAS PERFORMED, THE WOUND CLOSURE WAS ONCE PERFORMED. THE SCREW WAS PILLED OUT AT THE SAME TIME WHEN REMOVING THE CROSS LINK, AND A SLIGHT PEDICLE FRACTURE OCCURRED ON THE LEFT OF L2. THE PROCEDURE ON L2 WAS SKIPPED, AND THE FIXING RANGE WAS EXTENDED UNTIL L1. THE SCREW THAT HAD BEEN INSERTED AT LEFT L2 WAS USED FOR RIGHT L1. THERE WAS A DELAY OF 60 MINUTES OR MORE AS A RESULT OF THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1275758 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H5546113

    Patients

    Seq Age Sex Outcome Treatment
    1