BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SATELLITE SPINAL SYSTEM

    MDR report key: 2424953 · Received January 23, 2012

    Report

    Report Number
    1030489-2012-00075
    Event Type
    Injury
    Date Received
    January 23, 2012
    Report Date
    December 27, 2011
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NVR
    PMA / PMN Number
    K051320
    Removal / Correction Number
    1030489-092707-008-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE OR APPLICABLE IMAGING STUDIES WERE NOT PROVIDED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CT AND MYELOGRAM DONE ON (B)(6) 2011 SHOWED A FAILED INTERBODY FUSION AT L4-5, AND NARROWING OF THE L5-S1 DISC.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT THE PATIENT WAS PRE-OPERATIVELY EXPERIENCING RECURRING LOWER BACK PAIN AND PAIN-PRODUCING DEGENERATIVE CHANGES. THE PATIENT UNDERWENT POSTERIOR SPINAL SURGERY IN WHICH A SPHERICAL INTERBODY DEVICE WAS IMPLANTED AT THE L4-5 LEVEL. REPORTEDLY THE PATIENT DEVELOPED NEUROLOGICAL INJURIES POST-OP AND LATER UNDERWENT ANOTHER PROCEDURE FOR REMOVAL OF THE DEVICE. THE PATIENT CURRENTLY RECEIVES PAIN MANAGEMENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SATELLITE SPINAL SYSTEM PROSTHESIS, INTERVERTEBRAL DISC NVR WARSAW ORTHOPEDICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention