BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR HEAD/COCR

    MDR report key: 3192953 · Received December 22, 2006

    Report

    Report Number
    1825034-2006-00136
    Event Type
    Injury
    Date Received
    December 22, 2006
    Manufacturer
    BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K911684
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. THIS REPORT FILED ON DEC 22, 2006.

    Description of Event or Problem · 1

    REF USER FACILITY # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR HEAD/COCR JDI BIOMET, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1