BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2132749 · Received June 17, 2011

    Report

    Report Number
    1030489-2011-00758
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Report Date
    August 15, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    KWP
    PMA / PMN Number
    K052187
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    THE LOOSE OF THE L4 AND/OR L5 SETSCREWS MAY BE EXPLAINED BY THE UN-PROPER BENDING AND INSERTION OF THE ROD INTO THE ROD CANAL OF THE FAS. X-RAYS MAY CONFIRM OR NOT THIS HYPOTHESIS (NO X-RAYS RECEIVED AT THE TIME OF THIS REPORT).

    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

    NO EVAL EXPLAIN CODE. 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. DURING THE PROCEDURE, THE SET SCREW ON THE LEFT SIDE AT S1 COULD NOT BE BROKEN OFF DUE TO THE ANGLE OF THE SCREW. THE SURGEON DECIDED TO LEAVE THE SCREW IN THE PATIENT UNBROKEN.

    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 H11B3425

    Patients

    Seq Age Sex Outcome Treatment
    1