BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    MDR report key: 7562944 · Received June 1, 2018

    Report

    Report Number
    3006179046-2018-00043
    Event Type
    Injury
    Date Received
    June 1, 2018
    Date of Event
    May 2, 2018
    Report Date
    May 2, 2018
    Manufacturer
    NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
    Product Code
    PGN
    PMA / PMN Number
    K140613
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ROD 1 LOT # 150128-10: A VISUAL INSPECTION OF THE RETURNED ROD REVEALED IT WAS PARTIALLY DISTRACTED. FUNCTIONAL TESTING REVEALED THAT THE ROD COULD DISTRACT AND RETRACT WITH THE MANUAL DISTRACTOR. IT WAS DETERMINED THE ROD WAS FUNCTIONAL. ROD 2 LOT # 150428-13: A VISUAL INSPECTION OF THE RETURNED ROD REVEALED IT WAS PARTIALLY DISTRACTED. FUNCTIONAL TESTING REVEALED THE ROD COULD NOT BE DISTRACTED OR RETRACTED USING THE MANUAL DISTRACTOR. THE ROD WAS ABLE TO BE DISTRACTED AND RETRACTED WITH THE ERC. THE ROD WAS OBSERVED TO HAVE SCORE MARKS AND DEBRIS BUILD UP, WHICH MAY HAVE CAUSED THE REDUCED FUNCTIONALITY OF THE ROD.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402210 MAGEC SPINAL BRACING AND DISTRACTION SYSTEM GROWING ROD SYSTEM-MAGNETIC ACTUATION PGN NUVASIVE SPECIALIZED ORTHOPEDICS, INC. MS1-4590S A141118-01, A141210-01

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Hospitalization| R