BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFS II PARALLEL ROD CONNECTORS

    MDR report key: 2455939 · Received February 1, 2012

    Report

    Report Number
    3008524126-2012-00002
    Event Type
    Malfunction
    Date Received
    February 1, 2012
    Date of Event
    December 30, 2011
    Report Date
    January 30, 2012
    Manufacturer
    ORTHOFIX INC.
    Product Code
    MNI
    PMA / PMN Number
    K080407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BASED ON INFO PROVIDED, THE TWO MULTI-AXIAL CROSS CONNECTORS BROKE. THE PRODUCT WAS REPLACED AND PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SFS II PARALLEL ROD CONNECTORS SFS II PARALLEL ROD CONNECTORS MNI ORTHOFIX INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other