BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGEC® SPINAL BRACING AND DISTRACTION SYSTEM

    MDR report key: 5640811 · Received May 9, 2016

    Report

    Report Number
    3006179046-2016-00011
    Event Type
    Injury
    Date Received
    May 9, 2016
    Report Date
    April 12, 2016
    Manufacturer
    NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
    Product Code
    PGN
    PMA / PMN Number
    K140178
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A PATIENT'S DUAL MAGEC RODS WERE REMOVED AFTER OVER ONE (1) YEAR OF IMPLANTATION; THE RODS WERE ALLEGEDLY BROKEN. THE DEVICES (LOT# A140605-01, EXPIRATION DATE 06/01/2016, AND LOT# A140220-03, EXPIRATION DATE 02/01/2016) WERE INITIALLY IMPLANTED IN (B)(6) 2014. NO FURTHER INFORMATION WAS RECEIVED WITH REGARD TO THE PATIENT'S HEALTH AND NO DETAILS SURROUNDING THE PATIENT'S PROCEDURE WAS PROVIDED. NO PATIENT INFORMATION WAS PROVIDED. TO DATE, THE DEVICES HAS NOT BEEN RETURNED; THEREFORE, NO EVALUATION CAN BE CONDUCTED. A DHR REVIEW REVEALED THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS, AND THE DEVICES WERE RELEASED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S DUAL MAGEC RODS WERE REMOVED AFTER OVER ONE (1) YEAR OF IMPLANTATION; THE RODS WERE ALLEGEDLY BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295493 MAGEC® SPINAL BRACING AND DISTRACTION SYSTEM GROWNING ROD SYSTEM-MAGNETIC ACTUATION PGN NUVASIVE SPECIALIZED ORTHOPEDICS, INC. RA002-5555SL, RA002-55555SLR A140605-01, A140220-03

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization