BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2821583 · Received November 6, 2012

    Report

    Report Number
    1030489-2012-02005
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 9, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    K052187
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE WAS NOT RETURNED FOR EVALUATION. FILMS WERE SUPPLED FOR REVIEW WHICH FOUND MULTIPLE PLAIN X-RAYS OF POST-OP SCOLIOSIS FUSION AT T4-L4. SUBSEQUENT FILMS SHOW DISENGAGEMENT OF ROD AND LOWER 4 SCREWS DUE TO SET SCREW BACK OUT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL SURGICAL PROCEDURE AT T2-L4 FOR SCOLIOSIS CORRECTION. IT WAS REPORTED THAT SOMETIME POST-OP THE SETSCREWS BACKED OUT OF THE UNIAXIAL SCREWS AT L1, L2, L3, AND L4. IT WAS FOUND THAT THERE WAS PSEUDOARTHROSIS AT L2-3 AND L3-4. THE PATIENT UNDERWENT A REVISION SURGERY IN WHICH THE HARDWARE WAS REMOVED AND AN ONLAY FUSION OF AUTOGRAFT AND ALLOGRAFT WAS PERFORMED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00018 YR Required Intervention RODS, SCREWS