BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2132746 · Received June 17, 2011

    Report

    Report Number
    1030489-2011-00757
    Event Type
    Injury
    Date Received
    June 17, 2011
    Report Date
    August 15, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    KWP
    PMA / PMN Number
    K031655
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION FOUND THAT THE INNER THREAD CREST IS DAMAGE AND THE UPPER SURFACE OF THE THREAD IS WORN. THIS CAN BE ATTRIBUTED TO EXTRA LOAD APPLIED BY THE SETSCREW. THE HEAD SURFACE IS WORN AND PRESENTS NOTCHES DUE TO EXPLANTATION MANEUVERS. THE DAMAGE OF THE FAS AND AN UNBROKEN SETSCREW CONFIRMS THE SUSPICION FROM THE SURGEON OF SETSCREW MIS-POSITIONED (CROSS-THREADED).

    Additional Manufacturer Narrative · 1

    THE DEVICE 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. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT LUMBAR FIXATION AT L4-L5-S1 WITH FIXED ANGLE SCREWS. A FEW DAYS AFTER SURGERY, THE PATIENT STARTED TO COMPLAIN ABOUT BACK AND LEG PAIN. X-RAY IMAGES SHOWED THAT THE LEFT S1 SCREW WAS LOOSE, AND POSSIBLY, ACCORDING TO THE SURGEON, MISPOSITIONED. 14 DAYS POST OP THE PATIENT UNDERWENT A REVISION SURGERY TO REPLACE THE LOOSE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS H10J0859

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention