BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 5259817 · Received December 2, 2015

    Report

    Report Number
    1030489-2015-03285
    Event Type
    Injury
    Date Received
    December 2, 2015
    Report Date
    November 16, 2015
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE CAUSE OF EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FEMALE PATIENT UNDERWENT POSTERIOR FIXATION WITH PERCUTANEOUS PEDICLE SCREWS AND SAGITTAL ADJUSTING SCREW (SAS) AT LEVELS L1-L3 FOR L2 BURST FRACTURE AND THE VERTEBROPLASLY WAS PERFORMED WITH HA BLOCK AT L2 IN (B)(6) 2015. POST-OP, L1 PLACED SCREW WAS LOOSENED SO ALIGNMENT WAS UNSTABLE IN MIDDLE OF (B)(6) 2015. THE SURGEON CONSIDERED THAT THE ALIGNMENT MIGHT BE AGGRAVATED GRADUALLY SO REVISION SURGERY WAS PERFORMED TO REMOVE ALL SAS SCREWS AND EXTEND FUSION FROM L1-L3 LEVELS TO TH11-L4 LEVELS ON (B)(6) 2015. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790392 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention