BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT X-DRIVE SCREW

    MDR report key: 3994191 · Received August 8, 2014

    Report

    Report Number
    0001032347-2014-00237
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 17, 2014
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK001238
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. PAIN IS A PERCEPTION BY THE PATIENT AND THE CAUSE OF PAIN CANNOT BE DETERMINED TO BE A RESULT OF THE IMPLANT'S FORM, FIT, OR FUNCTION. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. FILE 6 OF 6.

    Description of Event or Problem · 1

    A REVISION SURGERY DUE TO PAIN WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467708 HT X-DRIVE SCREW BONE SCREW JEY BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization