BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 4101006 · Received September 19, 2014

    Report

    Report Number
    1030489-2014-03716
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    K052187
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FILMS WERE SUPPLIED FOR REVIEW. EVALUATION OF THE FILMS IS NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). LOCATION : HOSPITAL. THE SCREW HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: VISUALLY, OPTICALLY, AND MICROSCOPICALLY EXAMINED SET SCREW ROD INTERFACE SURFACE. NO DAMAGE IDENTIFIED TO SET SCREW THREAD CREST OR FLANKS. BREAK-OFF SET SCREW NODE HEIGHT AND MORPHOLOGY OF DEFORMATION FOUND TO BE CONSISTENT WITH FULL TIGHTENING AND ENGAGEMENT OF SET SCREW. AFTER VISUAL, OPTICAL AND MICROSCOPIC EXAMINATION, NO EVIDENCE WAS FOUND THAT WOULD SUGGEST A DEFECT IN MANUFACTURING OR PROCESSING OF THE IMPLANTS; UNABLE TO DETERMINE ROOT CAUSE OF THE FOREGOING EVENT FROM THE AVAILABLE INFORMATION. FILMS SUPPLIED FOUND: THIS CASE IS REPRESENTED BY AN AP AND LATERAL X-RAY SHOWING THE UPPER END OF A LONG THORACIC OR THORACOLUMBAR CONSTRUCT. WHETHER THIS IS FOR KYPHOSIS OR A FRACTURE BELOW THE LEVEL OF THE PICTURES IS NOT SEEN BUT THE LENGTH OF THE CONSTRUCT SUGGESTS A DEFORMITY CASE. BOTH FILMS SHOW THE UPPER SCREWS AT ABOUT T3 WITH THE RODS LIFTED OUT OF THE TULIPS OF THE PEDICLE SCREWS BILATERALLY, THE SET SCREWS LOOSE IN SOFT TISSUE AND PARTIAL RECURRENCE OF KYPHOSIS. ON THE LEFT THE SET SCREW IS ALSO BACKED OUT AND THE ROD ELEVATED FROM THE SCREW AT T5. ON THE RIGHT THIS CANNOT BE VERIFIED AT T6. THE REMAINDER OF THE CONSTRUCT APPEARS INTACT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL SURGICAL PROCEDURE. IT WAS REPORTED THAT SOMETIME POST ¿OP THE SET SCREW POPPED OUT OF THE BONE SCREW. THE PATIENT UNDERWENT A REVISION SURGERY TO HAVE TO REPLACE THE SCREW. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584475 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H13A4535

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention