BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SATELLITE SPINAL SYSTEM

    MDR report key: 1259228 · Received December 4, 2008

    Report

    Report Number
    1030489-2008-00657
    Event Type
    Injury
    Date Received
    December 4, 2008
    Report Date
    June 13, 2016
    Manufacturer
    SOFAMOR DANEK DEGGENDORF GMBH
    Product Code
    NVR
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PATIENT THAT HE HAD UNDERGONE A SPINAL PROCEDURE AND WAS IMPLANTED AN INTERBODY DEVICE IN 2007. THE PATIENT STATED THAT HE HAD THE MULTIPLE POST OP COMPLICATIONS SUCH AS RENAL ISSUES, LEG SWELLING, AND SEVERE LEG PAIN AFTER THE PROCEDURE. THE DEVICE WAS REMOVED APPROXIMATELY FOUR MONTH POST OP IN THREE MONTHS LATER.

    Description of Event or Problem · 1

    AS AN ADDITIONAL INFORMATION, IT WAS REPORTED BY THE PATIENT THAT HE COULDN'T WALK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SATELLITE SPINAL SYSTEM SPHERE NVR SOFAMOR DANEK DEGGENDORF GMBH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention