BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CROSSLINK 50MM

    MDR report key: 2987651 · Received February 28, 2013

    Report

    Report Number
    3005739886-2013-00008
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 24, 2013
    Manufacturer
    FMI MEDICAL INSTRUMENTS
    Product Code
    MNI
    PMA / PMN Number
    K092128
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 1

    DURING PROCEDURE PERFORMED (B)(6) 2013, THE SET SCREW WHICH TIGHTENS THE CROSSLINK TO THE ROD FRACTURED AND BROKE INTO TWO (2) PIECES. THE TIP PORTION OF THE SET SCREW FELL INTO THE PATIENT'S WOUND AND WAS RETRIEVED BY THE DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86676 CROSSLINK 50MM PEDICAL SCREW SPINAL SYSTEM MNI FMI MEDICAL INSTRUMENTS 1155FM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention