BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3006179046-2018-00103

    MDR report key: 8031332 · Received November 1, 2018

    Report

    Report Number
    3006179046-2018-00103
    Event Type
    Injury
    Date Received
    November 1, 2018
    Date of Event
    September 13, 2018
    Report Date
    October 2, 2018
    PMA / PMN Number
    K140613
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION OF THE MAGEC ROD (B)(4) REVEALED TO BE PARTIALLY DISTRACTED WITH SCORE MARKS ON THE DISTRACTION ROD. THE ROD COULD BE LENGTHENED BY HAND WHEN PULLING ON THE DISTRACTION ROD, WHICH CONFIRMS THE PIN FAILURE. DHR REVIEW REVEALED THIS UNIT WAS BUILT PRIOR TO THE RELEASE OF THE NEW PIN. A VISUAL INSPECTION FOR LOT (A150128-11) CONFIRMED TO BE BROKEN ON THE SOLID SECTION PORTION OF THE END CAP. A DIMPLE IN THE ROD WAS OBSERVED NEXT TO THE LOCATION OF THE BREAK INDICATING THE BREAK TO BE AT THE LOCATION OF THE FIXATION SCREW.

    Description of Event or Problem · 0

    THE MAGEC ROD, 4.5MM 90MM OFFSET REPORTEDLY IS FRACTURED. NO PATIENT INJURY REPORTED.

    Additional Manufacturer Narrative · 1

    DEVICE YET TO BE OBTAINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S MAGEC ROD IS DAMAGED. THE PHYSICIAN REVISED THE MAGEC ROD WITH A NEW MAGEC ROD WITHOUT INCIDENT.

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| R