BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2132730 · Received June 17, 2011

    Report

    Report Number
    1030489-2011-00753
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 17, 2011
    Report Date
    July 11, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    KWP
    PMA / PMN Number
    K052747
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    EVALUATION OF THE RETURNED DEVICE FOUND ONE LEG OF THE INNER SLEEVE IS BENT OUTWARD. THIS DEFORMATION IS MOVING THE CONNECTION LUG OUTWARDS, SO THAT THE INSTRUMENT IN ASSEMBLED POSITION IS NOT ABLE TO RETAIN A BONE SCREW HEAD. THE EDGE AT THE TOP OF THE IMPLANT HEAD CAPTURE IS DEFORMED DUE TO A HARD CONTACT WITH ANOTHER METAL ITEM. THE INNER SLEEVE WAS FOUND DAMAGED AT THE LEVEL OF THE CONNECTION WITH A BONE SCREW HEAD. NO DEFECT WAS FOUND AT THE LEVEL OF THE DAMAGES. ONE LEG OF THE INNER SLEEVE HAS BEEN BENT OUTWARD, CONSISTENT WITH THE APPLICATION OF HIGH LEVEL LATERAL LOADS WHILE THE EXTERNAL EXTENDER WAS ALREADY PARTIALLY REDUCED. THE ORIGIN OF THE LATERAL LOAD MAY COME FROM ONE OF THE FOLLOWING CONFIGURATIONS: THE SLEEVE WAS NOT FIXED CORRECTLY TO THE HEAD OF THE BONE SCREW. THE ARMS OF THE SLEEVE WOULD NOT BE PARALLEL PREVENTING FROM A GOOD SLIDING OF THE EXTENDER RESULTING IN LATERAL LOADS AGAINST THE SLEEVE. THE ROD IS PINCHED BETWEEN THE SLEEVE AND THE EXTENDER DURING THE REDUCTION, RESULTING IN LATERAL LOADS AGAINST THE SLEEVE. THIS MAY HAVE HAPPENED DURING A PREVIOUS SURGERY AND NOT BEEN DETECTED AT THAT TIME.

    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 BEFORE INSERTION, THE SCREW DETACHED FROM THE EXTENDER, AND THE INNER SLEEVE OF THE EXTENDER WAS BENT. THE INSTRUMENT WAS NOT USED ON THE PATIENT. NO 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 INSTRUMENT MANUFACTURING FA09G004

    Patients

    Seq Age Sex Outcome Treatment
    1