BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    MDR report key: 11938857 · Received June 4, 2021

    Report

    Report Number
    3006179046-2021-00295
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Date of Event
    May 5, 2021
    Report Date
    May 12, 2021
    Manufacturer
    NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
    Product Code
    PGN
    UDI-DI
    00812258022624
    PMA / PMN Number
    K171791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR VISUAL AND FUNCTIONAL TESTING. VISUAL INSPECTION REVEALED SCORE MARKS ON THE ROD CONSISTENT WITH INCREMENTAL DISTRACTION BUT NO DAMAGE. X-RAY IMAGES REVEALED A BROKEN RADIAL BEARING. FUNCTIONAL TESTING WAS PERFORMED WITH THE ELECTRONIC REMOTE CONTROLLER (ERC) AND MANUAL DISTRACTOR. THE ROD WAS UNABLE TO DISTRACTED OR RETRACTED. SECTIONING OF THE ROD WAS NOT PERFORMED. THE ROOT CAUSE OF THE REPORTED EVENT IS UNKNOWN, HOWEVER, WITH THIS TYPE OF FAILURE IT IS AN INDICATION OF LOAD BEARING WHICH EXCEEDED THE INSTRUCTED LIMITS BY THE PATIENT. REVIEW OF THE DEVICE HISTORY RECORDS INDICATED THAT UNIT MET ALL QUALITY SPECIFICATIONS PRIOR TO SHIPMENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE IS UNABLE TO BE DETERMINED AT THIS TIME. IF ANY ADDITIONAL PERTINENT INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED DUE TO THE ROD NOT LENGTHENING. NO PATIENT ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835364 MAGEC SPINAL BRACING AND DISTRACTION SYSTEM GROWING ROD SYSTEM - MAGNETIC ACTUATION PGN NUVASIVE SPECIALIZED ORTHOPEDICS, INC. MC2-4590S 8090402 00812258022624

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR