BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM SINGLE INNER SET SCREW

    MDR report key: 2103782 · Received May 24, 2011

    Report

    Report Number
    1526439-2011-00084
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    March 14, 2011
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    NKB
    PMA / PMN Number
    K033901
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICE FOUND NO ANOMALIES. NO DEFINITIVE CONCLUSIONS CAN BE MADE. 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

    INTERNATIONAL AFFILIATE REPORTS THE PATIENT EXPERIENCED PAIN APPROXIMATELY ONE MONTH AFTER DEVICE IMPLANTATION. X-RAY IMAGE REVEALED THAT THE SINGLE INNER SET SCREW HAD LOOSENED FROM THE CONSTRUCT. REVISION SURGERY WAS PERFORMED TO REMOVE THE SET SCREW AND CONCOMITANT DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPEDIUM SINGLE INNER SET SCREW SPINAL FIXATION DEVICE NKB DEPUY SPINE, INC. NA ALPCDN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention EXPEDIUM MONOAXIAL SCREW: (B)(4)| LOT# UNKNOWN| LOT CODE BDDR9SR, QTY = 2| EXPEDIUM SINGLE INNER SET SCREW: (B)(4)