BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SATELLITE SPINAL SYSTEM

    MDR report key: 1297543 · Received January 22, 2009

    Report

    Report Number
    1030489-2009-00077
    Event Type
    Injury
    Date Received
    January 22, 2009
    Date of Event
    January 8, 2007
    Report Date
    December 31, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    NVR
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NON MEDICAL PROFESSIONAL THAT THE PATIENT UNDERWENT A FUSION PROCEDURE AT L5-S1 IN 2005. THE SURGEON PERFORMED A LUMBAR LAMINECTOMY WITH MEDICAL FACETECTOMIES AND FORAMINOTOMIES, FOR COMPLETE DECOMPRESSION OF THE DURAL AND NEURAL ELEMENTS AND TRANSFORAMINAL INTERBODY FUSION. AN INTERBODY FUSION STABILIZATION DEVICE WAS USED AT L5-S1. AT AN UNKNOWN TIME POST-OP, THE PATIENT EXPERIENCED SEVERE BACK PAIN AND OTHER SYMPTOMS. IN EARLY 2007, THE SURGEON PERFORMED AN ADDITIONAL OPERATION ON THE PATIENT AT L5-S1 TO INSTALL PEDICLE SCREW INSTRUMENTATION. AFTER THIS SECOND SURGERY, THE PATIENT CONTINUES TO HAVE SEVERE SYMPTOMS, INCLUDING LOSS OF SENSATION, DIFFICULTY IN WALKING, AND DIFFICULTY SLEEPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SATELLITE SPINAL SYSTEM SPHERE NVR WARSAW ORTHOPEDIC INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention