BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM 6.35 SINGLE INNER SETSCREW

    MDR report key: 2265883 · Received September 27, 2011

    Report

    Report Number
    1526439-2011-00165
    Event Type
    Injury
    Date Received
    September 27, 2011
    Report Date
    September 27, 2011
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    HNH
    PMA / PMN Number
    K062174
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SETSCREWS WERE RETAINED BY THE USER FACILITY AND NOT MADE AVAILABLE. A DEFINITIVE CAUSE OF THE EVENT CANNOT BE DETERMINED AT THIS TIME. CARE MUST BE TAKEN TO ENSURE THAT THE CONSTRUCT FULLY TIGHTENED AND ASSEMBLED PROPERLY. CONSTRUCT LOOSENING IS LISTED AS A POSSIBLE ADVERSE OUTCOME IN THE INSTRUCTIONS-FOR-USE (IFU) SUPPLIED WITH THE DEVICE.

    Description of Event or Problem · 1

    CONTACT REPORTED THAT SURGEON NOTICED ON THE FILMS OF POST OP SURGERY 2-WEEKS OUT THAT AT LEAST 3 SETSCREWS HAD VISIBLY LOOSENED. SURGEON SCHEDULED THE PATIENT FOR REVISION SURGERY TO REPLACE AND DIAGNOSE THE OTHER IMPLANTS. UPON EXPLORATION, SURGEON NOTICED THAT LEFT SIDE CAPS WERE LOOSE AND SEVERAL ON THE RIGHT. HE REPLACED 7 SETSCREWS. AS AN ADVERSE OUTCOME WAS REPORTED AN MDR IS FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPEDIUM 6.35 SINGLE INNER SETSCREW ORTHOSIS SPONDYLOISTHESIS SPINAL FIXATION HNH DEPUY RAYNHAM

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention