BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    MDR report key: 14116167 · Received April 14, 2022

    Report

    Report Number
    3006179046-2022-00172
    Event Type
    Malfunction
    Date Received
    April 14, 2022
    Report Date
    April 14, 2022
    Manufacturer
    NUVASIVE SPECIALIZED ORTHOPEDICS
    Product Code
    PGN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE IS UNABLE TO BE DETERMINED AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. LITERATURE - TITLE OF ARTICLE: THE CROOKED ROD SIGN - A NEW RADIOLOGICAL SIGN TO DETECT DEFORMED THREADS IN THE DISTRACTION MECHANISM OF MAGNETICALLY CONTROLLED GROWING RODS AND A MODE OF DISTRACTION FAILURE - AUTHORS: JASON PUI YIN CHEUNG, TENG ZHANG, CORA BOW, KENNY KWAN, KAM YIN SZE, KENNETH MAN CHEE CHEUNG. PUBLICATION DATE: 2019.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED VIA LITERATURE THAT UPON REVIEW OF OTHER PATIENTS WHO HAVE EXPERIENCED DISTRACTION FAILURES AND CONTINUOUS ROD SLIPPAGE (OBSERVED IN 8 PATIENTS), NONE OBSERVED SIMILAR CROOKED ROD SIGN ON FOLLOW-UP RADIOGRAPHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168163 MAGEC SPINAL BRACING AND DISTRACTION SYSTEM GROWING ROD SYSTEM - MAGNETIC ACTUATION PGN NUVASIVE SPECIALIZED ORTHOPEDICS UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown