BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2991657 · Received March 6, 2013

    Report

    Report Number
    1030489-2013-00698
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    May 7, 2012
    Report Date
    February 11, 2013
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWQ
    PMA / PMN Number
    K042025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER DEVICE NOR APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE FOR L4-S1 LAMINECTOMY WITH L4-S1 PEDICLE SCREW FIXATION AND INTERBODY FUSION AT L5-S1 WITH PEEK CAGE. PREOPERATIVE DIAGNOSIS WAS BILATERAL L5 PARS DEFECT WITH GRADE I LISTHESIS AT L5-S1 AND SPINAL INSTABILITY. THE PATIENT DID WELL POST-OP AND THEN DEVELOPED PROGRESSIVELY WORSENING LOWER BACK PAIN. X-RAYS TAKEN APPROXIMATELY 6 MONTHS POST-OP FOUND THE RIGHT S1 SCREW BROKEN. THE PATIENT UNDERWENT ADDITIONAL SURGERY FOR PSEUDOARTHROSIS WITH SCREW FRACTURE AT RIGHT S1 AND LUMBAR RADICULOPATHY. PROCEDURE WAS FOR REDO ARTHRODESIS AT L4-L5-S1 AND REPLACEMENT OF BOTH S1 SCREWS. POST-OP THE PATIENT REPORTED DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95945 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MDT SOFAMOR DANEK PUERTO RICO MFG NA H09B2813

    Patients

    Seq Age Sex Outcome Treatment
    1 00032 YR Required Intervention