BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    MDR report key: 8489143 · Received April 5, 2019

    Report

    Report Number
    3006179046-2019-00109
    Event Type
    Injury
    Date Received
    April 5, 2019
    Date of Event
    February 1, 2019
    Report Date
    March 8, 2019
    Manufacturer
    NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
    Product Code
    PGN
    PMA / PMN Number
    K140613
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ROD 1, LOT #A151116-24: A VISUAL INSPECTION OF THE RETURNED ROD REVEALED IT WAS PARTIALLY DISTRACTED WITH SCORE MARKS ON THE DISTRACTION ROD. FUNCTIONAL TESTING WITH THE MANUAL DISTRACTOR AND ERC REVEALED THAT THE ROD WAS ABLE TO DISTRACT OR RETRACT. 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. ROD 2, LOT # A150717-12: A VISUAL INSPECTION OF THE RETURNED ROD REVEALED IT WAS PARTIALLY DISTRACTED WITH SCORE MARKS ON THE DISTRACTION ROD. FUNCTIONAL TESTING WITH THE MANUAL DISTRACTOR AND ERC REVEALED THAT THE ROD WAS UNABLE TO DISTRACT OR RETRACT USING THE MANUAL DISTRACTOR AND/OR ERC. THE ROD WAS CUT OPEN AND DEBRIS BUILD UP WAS FOUND, WHICH MAY HAVE CAUSED THE REDUCED FUNCTIONALITY. 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 · 0

    RODS ORIGINALLY IMPLANTED IN (B)(6) 2017. APPROXIMATELY 1-1.5CM OF DISTRACTION WAS ACHIEVED AND RODS THEN STOPPED LENGTHENING FOR 6 MONTHS. AT THAT TIME, A PRIMARY FUSION WAS PERFORMED ON THE PATIENT. NO COMPLICATIONS OTHER THAN APPARENT ROD MALFUNCTION WERE REPORTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: DEVICE HAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALLEGEDLY THE PATIENT'S MAGEC RODS WOULD NOT DISTRACT. THEREFORE, THE PHYSICIAN PERFORMED A PRIMARY FUSION ON THE PATIENT WITH NO COMPLICATIONS. THE PATIENT HAD BEEN IMPLANTED WITH THE MAGEC RODS FOR ALMOST (2) YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282352 MAGEC SPINAL BRACING AND DISTRACTION SYSTEM GROWING ROD SYSTEM-MAGNETIC ACTUATION PGN NUVASIVE SPECIALIZED ORTHOPEDICS, INC. MS1-5570S A150717-12, A151116-24

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization| R