BEUDAMED
    FDA Adverse Event Other Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 2864340 · Received December 6, 2012

    Report

    Report Number
    3004485144-2012-00041
    Event Type
    Other
    Date Received
    December 6, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    LANX, INC.
    Product Code
    MNI
    PMA / PMN Number
    043484
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED PRODUCT WAS RETURNED AND VISUALLY INSPECTED. THE REPORTED ISSUE WAS CONFIRMED. THE AVAILABLE INFORMATION SUGGESTS THAT PATIENT OBESITY CONTRIBUTED TO THE NEED FOR REVISION. REVIEW OF THE ASSOCIATED IFU IDENTIFIED MORBID OBESITY AS A CONTRAINDICATION AND SECOND SURGERY AND BREAKAGE AS POSSIBLE COMPLICATIONS. REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DISCREPANCIES WHICH COULD HAVE CONTRIBUTED TO THE EVENT. THERE IS NO EVIDENCE TO INDICATE THAT THE PRODUCT WAS MANUFACTURED OUT OF SPECIFICATION.

    Description of Event or Problem · 1

    PATIENT UNDERWENT INITIAL POSTERIOR INSTRUMENTATION OF L4-S1 APPROXIMATELY 1.5-2.0 YEARS AGO. SUCCESSFUL FUSION ACHIEVED, BUT PROGRESSION OF DISEASE TO L3 NECESSITATED REVISION TO INSTRUMENT ADJACENT LEVEL. TWO OF THE ORIGINAL PEDICLE SCREWS BROKE DURING ATTEMPTED REMOVAL, AND THIS LED TO A SURGICAL DELAY OF 45 MINUTES. ONE OF THESE PEDICLE SCREWS WAS SUCCESSFULLY EXTRACTED, BUT SCREW SHANK COMPONENT OF THE OTHER WAS LEFT IN THE PEDICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX SPINAL FIXATION SYSTEM PEDICLE SCREW SPINAL SYSTEM MNI LANX, INC. 7715-8535 LX-2570

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SET SCREW COMPONENT: (B)(4)| ROD COMPONENT: (B)(4)