BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2012131 · Received March 9, 2011

    Report

    Report Number
    1030489-2011-00261
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 8, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    KWP
    PMA / PMN Number
    K052747
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INSTRUMENT WAS RETURNED FOR EVALUATION. VISUAL 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. VISUAL AND OPTICAL INSPECTION IDENTIFIED MULTIPLE AREAS OF DAMAGE. A FUNCTIONAL EVALUATION WAS PERFORMED; THE SUBJECT INSTRUMENT PROPERLY RETAINED BOTH LMC AND MMC MATING PART SIMULATIONS. ADDITIONALLY, A FUNCTIONAL EVALUATION WAS PERFORMED ON ALL SLEEVES AND EXTENDERS UTILIZING A SAMPLE MULTI-AXIAL SCREW (MAS); THE MAS HEAD WAS UNABLE TO BE MANUALLY PULLED OUT OF THE INNER SLEEVES WITH THE BONE SCREW AT MAXIMUM ANGULATION. SURGICAL TECHNIQUE FOR THIS PART IS FOR THE SURGEON TO REMOVE THE EXTENDER FROM THE BODY AND SCREW BY ROCKING THE EXTENDER IN A MEDIAL/LATERAL DIRECTION AND PULLING UPWARD. THIS CAN CREATE STRESSES ON THE PART THAT CAN BEND THE TIPS IF PERFORMED AGGRESSIVELY. WITNESS MARKS ON THE UPPER WALLS AND SIDES OF THE INNER SLEEVE, IN CONJUNCTION WITH THE RECENT LOT DATE CODE OF THE EVALUATED PRODUCT SUGGEST THAT AGGRESSIVE RELEASE TECHNIQUES MAY HAVE BEEN UTILIZED. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY APPLICABLE NONCONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A MINIMAL ACCESS SURGICAL PROCEDURE. IT WAS REPORTED THAT THE EXTENDER WOULD NOT STAY ATTACHED TO THE BONE SCREW WHEN APPLIED. 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 NA FA09E009

    Patients

    Seq Age Sex Outcome Treatment
    1 OUTER SLEEVE