BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SATELLITE SPINAL SYSTEM

    MDR report key: 939844 · Received November 6, 2007

    Report

    Report Number
    1030489-2007-00338
    Event Type
    Injury
    Date Received
    November 6, 2007
    Report Date
    October 31, 2007
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    NVR
    PMA / PMN Number
    K051320
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN RETURNED TO THE MFR; THEREFORE, PRODUCT EVALUATION IS NOT POSSIBLE.

    Description of Event or Problem · 1

    DATE OF IMPLANT: 2007. IT WAS REPORTED THAT A PT UNDERWENT A SURGICAL PROCEDURE WITH IMPLANTATION OF A SPHERE DEVICE. AT AN UNKNOWN TIME POST-OP, PT SUSTAINED A TRAUMATIC FALL ON SOME ICE. XRAYS REPORTEDLY REVEALED THAT THE IMPLANT HAD MIGRATED POSTERIORLY. PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE IMPLANT, APPROX 1 1/2 MONTHS POST-OP. 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 W05K0561

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention