BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2803279 · Received October 24, 2012

    Report

    Report Number
    1030489-2012-01963
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    September 27, 2012
    Report Date
    September 27, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NKB
    PMA / PMN Number
    K102807
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): MACROSCOPIC AND OPTICAL EXAMINATION OF THE TIP OF THE REDUCTION SLEEVES DID NOT IDENTIFY ANY BREAKAGE OR CRACKING. DIMENSIONAL EXAMINATION OF THE TIP OF THE REDUCTION SLEEVE FOUND THAT THE SLEEVE TIPS ARE BENT OUTWARD OUT OF PRINT SPECIFICATION AT THE MAS HEAD RETENTION FEATURES. EVALUATION WITH SAMPLE SOLERA MAS WAS UNABLE TO BE REMOVED WHEN ANGLED AT MAXIMUM ANGULATION AND MANUALLY BEND STRESS LOADING. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH BEND STRESS OVERLOAD.

    Additional Manufacturer Narrative · 1

    (B)(6): THE DEVICES HAVE 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

    MACROSCOPIC AND OPTICAL EXAMINATION OF THE TIP OF THE REDUCTION SLEEVES DID NOT IDENTIFY ANY BREAKAGE OR CRACKING. DIMENSIONAL EXAMINATION OF THE TIP OF THE REDUCTION SLEEVE FOUND THAT THE SLEEVE TIPS ARE BENT OUTWARD OUT OF PRINT SPECIFICATION AT THE MAS HEAD RETENTION FEATURES. EVALUATION WITH SAMPLE MAS WAS UNABLE TO BE REMOVED WHEN ANGLED AT MAXIMUM ANGULATION AND MANUALLY BEND STRESS LOADING. DIMENSIONAL EXAMINATION OF THE INNER M12 MAJOR DIAMETER CONFIRMED CONFORMANCE TO SPECIFICATION. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH BEND STRESS OVERLOAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A MINIMALLY INVASIVE POSTERIOR SURGICAL PROCEDURE AT L5-S1. IT WAS REPORTED THAT THE INNER SLEEVE POPPED OFF OF THE SCREW. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A MINIMALLY INVASIVE POSTERIOR SURGICAL PROCEDURE AT L5-S1. IT WAS REPORTED THAT THE INNER SLEEVE POPPED OFF OF THE SCREW. IT WAS REPORTED THAT THE SURGERY WAS CONVERTED INTO A MINI OPEN PROCEDURE. NO ADDITIONAL PATIENT C OMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK USA, INC NA RS12B039

    Patients

    Seq Age Sex Outcome Treatment
    1 EXTENDERS