BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXPANDABLE LUMBAR INTERBODY SYSTEM

    MDR report key: 3834837 · Received May 9, 2014

    Report

    Report Number
    2031966-2014-00030
    Event Type
    Other
    Date Received
    May 9, 2014
    Date of Event
    March 12, 2014
    Report Date
    May 9, 2014
    Manufacturer
    NUVASIVE, INC.
    Product Code
    MAX
    PMA / PMN Number
    K130820
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CT SCAN OF THE INTERBODY DEVICE WAS REVIEWED, CONFIRMING THE MIGRATION. IT IS UNK IF ENDPLATE PREPARATION, PLACEMENT OR THE PT'S FALL CONTRIBUTED TO THE RETROPULSION OF THE DEVICE, CAUSING LEG PAIN. THE RETURNED DEVICE MEASUREMENTS MET DESIGN SPECIFICATION. THERE IS NO FAILURE OF THE DEVICE. REVIEW OF THE DEVICE HISTORY RECORDS NO MATERIAL NON-CONFORMANCES OR MFG ERRORS THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS MODE OF FAILURE. THE ROOT CAUSE OF THIS REPORTED EVENT HAS NOT BEEN DETERMINED; NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE REPORT INDICATES THAT 6 WEEKS POST OPERATIVELY, THE INTERBODY FUSION DEVICE AT L5-L6 (TRANSITIONAL ANATOMY) HAD MIGRATED POSTERIORLY. THE PT HAD RESULTANT LEG PAIN. REVISION SURGERY WAS PERFORMED (B)(6) 2014, AND AN ALIF DEVICE WAS PLACED. PT IS REPORTEDLY DOING WELL POST REVISION. INFO SUGGEST THAT THE PT MAY HAVE FALLEN AFTER INITIAL SURGERY. PT'S ACTIVITY LEVEL IS UNK. PT COMPLIANCE WITH POST-SURGICAL INSTRUCTIONS IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280276 EXPANDABLE LUMBAR INTERBODY SYSTEM INTERVERTEBRAL BODY FUSION DEVICE MAX NUVASIVE, INC. 1642008 ST43165

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention