BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SATELLITE SPINAL SYSTEM

    MDR report key: 1209057 · Received October 16, 2008

    Report

    Report Number
    1030489-2008-00581
    Event Type
    Injury
    Date Received
    October 16, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 22, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC
    Product Code
    NVR
    PMA / PMN Number
    K060415
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTERBODY DEVICE WAS EXPLANTED APPROXIMATELY 11 MONTHS POST OP, DUE TO POST OP PAIN. THE IMPLANT LEVEL WAS AT L5-S1. NO OTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SATELLITE SPINAL SYSTEM SPHERE NVR WARSAW ORTHOPEDIC INC NA NC36

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention