BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX SPINAL FIXATION SYSTEM

    MDR report key: 7023859 · Received November 13, 2017

    Report

    Report Number
    9617297-2017-00005
    Event Type
    Injury
    Date Received
    November 13, 2017
    Date of Event
    October 17, 2017
    Report Date
    October 23, 2017
    Manufacturer
    U&I CORPORATION
    Product Code
    MNH
    PMA / PMN Number
    K091725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TWO PEDICLE SCREWS WERE EVALUATED. CHEMICAL COMPOSITION OF THEM WAS WITHIN ACCEPTABLE RANGE SPECIFIED IN ASTM F136 STANDARD AND THEIR MEASUREMENTS WERE WITHIN TOLERANCE SPECIFIED IN THE ENGINEERING DRAWING. THE LOOSENING AND FRACTURE OF PEDICLE SCREWS WERE BECAUSE OF THE NONUNION.

    Description of Event or Problem · 1

    PATIENT UNDERWENT SURGERY TO TREAT LUMBAR SPINAL STENOSIS ON (B)(6) 2015, BUT THE PEDICLE SCREWS WERE LOOSE AT L5 POST-OPERATIVELY. THE LOOSE SCREWS WERE REPLACED WITH LARGER PEDICLE SCREWS AND THE CONSTRUCT WAS REVISED ON (B)(6) 2017. TWO PEDICLE SCREWS REPLACED WERE FRACTURED SEVEN MONTHS LATER AND THE PATIENT UNDERWENT THE 3RD SURGERY ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804262 PERFIX SPINAL FIXATION SYSTEM SPINAL FIXATION SYSTEM MNH U&I CORPORATION 15B218

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention