BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM 6.35 TITANIUM SET SCREW

    MDR report key: 1910685 · Received November 22, 2010

    Report

    Report Number
    1526439-2010-00168
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 28, 2010
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    MNH
    PMA / PMN Number
    K062174
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEFINITIVE CAUSE OF THE EVENT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, CARE MUST BE TAKEN TO ENSURE THAT THE CONSTRUCT IS TIGHTENED 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 REPORTS PATIENT PRESENTED WITH FOUR LOOSE AND DISPLACED SET SCREWS WHICH RESULTED IN ROD DISPLACEMENT. REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE THE SET SCREWS AND RODS. THIS MEDWATCH REPORTS IS BEING FILED FOR THREE SET SCREWS, LOT ALDCYB. SEE MFG MEDWATCH REPORT# 1526439-2010-00169 FOR THE FOURTH SET SCREW, FROM A DIFFERENT LOT, THAT WAS INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPEDIUM 6.35 TITANIUM SET SCREW SPINAL FIXATION DEVICE MNH DEPUY SPINE, INC. NA ALDCYB

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention EXPEDIUM RODS, (B)(4) , QTY 2