BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1919630 · Received December 10, 2010

    Report

    Report Number
    1030489-2010-01551
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 12, 2010
    Report Date
    January 3, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    LXH
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE SUSPECT DEVICES IN USE ARE CATALOG # 7576305, LOT # SA09D163 AND CATALOG # 7576304, LOT # SA09J197. (B)(4): 510K FOR 7576305 AND 7576304 - K063417: MFG DATE FOR SA09D163 - 07/18/2009; MFG DATE FOR SA09J197 - 10/7/2009 NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE RETURNED FOR EVALUATION. MACROSCOPIC EXAMINATION DID NOT REVEAL ANY MATERIAL OR FUNCTIONAL ISSUE WITH RESPECT TO THE INSTRUMENTS. DIMENSIONAL EVALUATION OF THE INNER SLEEVE MAS RETENTION FEATURE DIMENSIONS FOUND TO BE WITHIN PRINT SPECIFICATION. A BENCH-TOP FUNCTIONAL EVALUATION FOUND PRODUCT ASSEMBLY ABLE TO BE FULLY REDUCED WITHOUT ISSUE, CONSISTENT WITH IMMEDIATE POST-OPERATIVE EVALUATION. ADDITIONALLY, THE PRODUCT WAS ASSEMBLED ONTO TEST FIXTURE DESIGNED TO SIMULATE INTRAOPERATIVE REDUCTION LOAD. THE INSTRUMENT FULLY REDUCED THE ROD, AS WELL AS UNREDUCED, AND WAS ABLE TO BE EASILY REMOVED WITHOUT ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A 2 LEVEL MINIMAL ACCESS SPINAL SURGERY AT L4-5. IT WAS REPORTED THAT DURING REDUCTION ON THE RIGHT SIDE OF L4 THE EXTENDER FROZE AND WOULD NOT MOVE UP OR DOWN. A MALLET WAS USED TO REMOVE THE EXTENDER WITHOUT SUCCESS. WITH THE EXTENDER UNABLE TO UNLOCK AND THE ROD JAMMED, IT WAS DECIDED TO UNSCREW THE CONSTRUCT. IT WAS NOTICED THAT THE L4 PEDICLE WAS FRACTURED ON THE RIGHT SIDE. THE SCREWS WERE REPOSITIONED AND WITH THE USE OF DIFFERENT EXTENDERS THE SURGERY WAS COMPLETED. SURGERY TIME WAS EXTENDED APPROXIMATELY 2.5 HOURS. NO OTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL LXH MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BONE SCREW