BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SATELLITE SPINAL SYSTEM

    MDR report key: 1309531 · Received February 6, 2009

    Report

    Report Number
    1030489-2009-00125
    Event Type
    Injury
    Date Received
    February 6, 2009
    Report Date
    January 20, 2009
    Manufacturer
    WARSAW ORTHOPAEDICS INC.
    Product Code
    NVR
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    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 SURGICAL PROCEDURE IN 2007 WHERE AN INTERBODY STABILIZATION DEVICE WAS IMPLANTED. AT UNKNOWN POINTS IN TIME AFTER THE INDEX PROCEDURE, THE PATIENT UNDERWENT FOUR SUBSEQUENT EXPLORATORY SURGICAL PROCEDURES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention