BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    MDR report key: 11397125 · Received March 1, 2021

    Report

    Report Number
    3006179046-2021-00165
    Event Type
    Malfunction
    Date Received
    March 1, 2021
    Report Date
    June 2, 2021
    Manufacturer
    NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
    Product Code
    PGN
    UDI-DI
    00856719002152
    PMA / PMN Number
    K171791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE RODS WERE RETURNED FOR VISUAL AND FUNCTIONAL TESTING. X-RAY IMAGES OF THE RODS REVEALED THAT BOTH HAD A BROKEN RADIAL BEARING, BROKEN CAGE AND THE INNER/OUTER RACES WERE MISALIGNED. FUNCTIONAL TESTING WAS PERFORMED AND THE RODS WERE UNABLE TO DISTRACT OR RETRACT WITH THE ELECTRONIC REMOTE CONTROLLER (ERC) AND MANUAL DISTRACTOR. SECTIONING OF THE RODS CONFIRMED THAT THE RADIAL BALL BEARINGS WERE BROKEN. IN ADDITION, THE SECTIONING OF THE RODS REVEALED HARDENED DEBRIS WAS BUILDUP. THE ROOT CAUSE IF THE REPORTED EVENT WAS UNABLE TO BE DETERMINED. A DEVICE HISTORY REVIEW (DHR) WAS PERFORMED ON BOTH RODS LOT NUMBER A170214-19 AND THERE WERE NO DEVIATIONS IN THE MANUFACTURING PROCESS AND THE FINISHED PRODUCT MET ALL ACCEPTANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. ROOT CAUSE IS UNABLE TO BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE. AS PER THE REPORTER, THE ROD LOCKED IN-SITU. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293450 MAGEC SPINAL BRACING AND DISTRACTION SYSTEM GROWING ROD SYSTEM - MAGNETIC ACTUATION PGN NUVASIVE SPECIALIZED ORTHOPEDICS, INC. RA002-5555SL70 A170214-19 00856719002152

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization