BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    MDR report key: 7749055 · Received August 3, 2018

    Report

    Report Number
    3006179046-2018-00052
    Event Type
    Injury
    Date Received
    August 3, 2018
    Date of Event
    June 28, 2018
    Report Date
    July 5, 2018
    Manufacturer
    NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
    Product Code
    HSB
    PMA / PMN Number
    K140613
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED THE ROD A150717-11 WAS FOUND PARTIALLY DISTRACTED WITH SCORE MARKS ON THE DISTRACTION ROD. FUNCTIONAL TESTING REVEALED THAT THE MANUAL DISTRACTOR AND ERC COULD NOT DISTRACT OR RETRACT THE ROD. SECTIONING OF THE ROD DETERMINED THAT THE DISTRACTION ROD COULD NOT BE SEPARATED FROM THE HOUSING WITHOUT USE OF HIGH FORCE. BENDING FORCES APPLIED TO THE ROD FROM PATIENT ANATOMY/ACTIVITY MAY HAVE CAUSED THE DISTRACTION ROD TO WEDGE INTO THE HOUSING TUBE, WHICH WOULD CAUSE THE FAILURE TO DISTRACT. A REVIEW OF THE LOT HISTORY RECORD FOR THE DEVICE REVEALED THAT THE DEVICE MET ALL OF THE REQUIRED QUALITY INSPECTIONS AND THAT THE PRODUCTS WERE RELEASED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS ALLEGED THAT THE PATIENT'S MAGEC RODR WOULD NOT DISTRACT. THE PHYSICIAN REVISED THE ROD WITH NEW MAGEC ROD WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590789 MAGEC SPINAL BRACING AND DISTRACTION SYSTEM GROWING ROD SYSTEM-MAGNETIC ACTUATION, HSB NUVASIVE SPECIALIZED ORTHOPEDICS, INC. MS1-4570S A15071711

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Hospitalization| R