BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    MDR report key: 11712665 · Received April 23, 2021

    Report

    Report Number
    3006179046-2021-00258
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Report Date
    July 19, 2021
    Manufacturer
    NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
    Product Code
    PGN
    UDI-DI
    00856719002190
    PMA / PMN Number
    K171791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: VISUAL INSPECTION OF RETURNED MAGEC ROD WAS NOT POSSIBLE DUE TO INCOMPLETE/PARTIAL RETURN OF THE INDICATED UNIT. THE PATIENT¿S X-RAY IMAGES INDICATE AND CONFIRM THE REPORTED FAILURE MODE. AS PART OF THIS INVESTIGATION, FUNCTIONAL TESTING WAS UNABLE TO BE PERFORMED DUE TO INCOMPLETE RETURN OF THE ENTIRE PRODUCT. THE WORK ORDER WAS REVIEWED, AND CONFIRMED THE DEVICE PASSED ALL INSPECTIONS. THE ROD HAS BEEN DETERMINED TO HAVE MET MANUFACTURING SPECIFICATIONS. THE BREAKAGE WAS NOT DETERMINED TO HAVE BEEN RELATED TO THE MANUFACTURING PROCESSES OR MATERIAL FAILURE. BASED ON THE TYPE OF BREAKAGE OBSERVED, IT IS LIKELY THE BREAKAGE RESULTED FROM THE PATIENT'S DAILY ACTIVITIES AND UNIQUE ANATOMICAL STRUCTURE. DEVICE RECORDS REVIEW: REVIEW OF THE DEVICE HISTORY RECORD FOR THE ROD CONFIRMED THAT IT MET ALL OF THE REQUIRED QUALITY INSPECTIONS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A ROD FRACTURE OCCURRED DISTALLY ABOVE THE SCREWS. NO PATIENT ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615530 MAGEC SPINAL BRACING AND DISTRACTION SYSTEM GROWING ROD SYSTEM - MAGNETIC ACTUATION PGN NUVASIVE SPECIALIZED ORTHOPEDICS, INC. RA002-5555SL 9010402AAC 00856719002190

    Patients

    Seq Age Sex Outcome Treatment
    1