BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SOLERA SPINAL SYSTEM

    MDR report key: 9469499 · Received December 13, 2019

    Report

    Report Number
    1030489-2019-01422
    Event Type
    Malfunction
    Date Received
    December 13, 2019
    Date of Event
    November 13, 2019
    Report Date
    December 13, 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. PRODUCT WAS NOT 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 L3-L5 LUMBAR SPINAL CANAL STENOSIS; AND UNDERWENT MONO-PORTAL TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT L3-L5. INTRA-OP, DURING FINAL TIGHTENING OF THE SET SCREW, IDLING OCCURRED. HENCE, THE SET SCREW WAS EXPLANTED; AND WAS REPLACED WITH A NEW ONE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1260585 CD HORIZON SOLERA SPINAL SYSTEM KWP WARSAW ORTHOPEDICS NA 0648714W

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR