BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFS SPINAL FIXATION SYSTEM

    MDR report key: 6489884 · Received April 13, 2017

    Report

    Report Number
    2183449-2017-00010
    Event Type
    Malfunction
    Date Received
    April 13, 2017
    Date of Event
    February 20, 2017
    Report Date
    April 13, 2017
    Manufacturer
    ORTHOFIX INC
    Product Code
    MNH
    PMA / PMN Number
    K994217
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION PROVIDED STATES THAT DURING A SPINE LUMBAR CASE TWO (2) MULTI-AXIAL SCREWS BROKE DURING FINAL TORQUE. SURGERY WAS COMPLETED WITH BACKUP PRODUCT. NO DELAYS IN THE CASE OR ADVERSE EVENTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271133 SFS SPINAL FIXATION SYSTEM MULTI-AXIAL SCREW, 6.5MM X 50MM MNH ORTHOFIX INC 56-3650 X 2 A12

    Patients

    Seq Age Sex Outcome Treatment
    1