BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM 4.5MM TITANIUM SET SCREW

    MDR report key: 2030906 · Received March 21, 2011

    Report

    Report Number
    1526439-2011-00040
    Event Type
    Injury
    Date Received
    March 21, 2011
    Date of Event
    February 23, 2011
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    NKB
    PMA / PMN Number
    K073364
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY SPINE HAS REQUESTED THE RETURN OF THE DEVICE. A F/U MEDWATCH REPORT WILL BE SUBMITTED UPON RECEIPT OF THE DEVICE AND COMPLETION OF THE EVAL.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT REVISION SURGERY WAS PERFORMED TO LENGTHEN THE PREVIOUSLY IMPLANTED CONSTRUCT. DURING THE PROCEDURE, IT WAS NOTED THAT TWO SETS SCREWS FROM THE ORIGINAL CONSTRUCT HAD LOOSENED AND THE RODS FROM THAT CONSTRUCT WERE MOVING FREELY WITHIN THE GROWTH CONNECTOR. IT WAS REPORTED THAT EXAMINATION OF THE DEVICES REVEALED THAT SURFACES OF THE SET SCREWS HAD SHEARED OFF IN SITU, RESULTING IN THE ROD MOVEMENT. AS THE IMPLANTED SET SCREW HAD LOOSENED, A MEDWATCH REPORT IS BEING SUBMITTED TO DOCUMENT THIS EVENT. MFG MEDWATCH REPORT #1526439-2011-00041 IS BEING FILED FOR THE SECOND SET SCREW THAT WAS INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPEDIUM 4.5MM TITANIUM SET SCREW SPINAL FIXATION DEVICE NKB DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention