BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REUNITE ORTHOPEDIC SCREW 2.8X25MM

    MDR report key: 2792544 · Received October 16, 2012

    Report

    Report Number
    0001825034-2012-01966
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    October 27, 2008
    Report Date
    September 19, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HWC
    PMA / PMN Number
    PK992301
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01965 / 01966).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT THE PATIENT UNDERWENT HALLUX VALGUS PROCEDURE ON (B)(6) 2008. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2008 DUE TO PATIENT ALLEGED REACTION TO THE IMPLANT. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REUNITE ORTHOPEDIC SCREW 2.8X25MM SCREW, FIXATION HWC BIOMET ORTHOPEDICS N/A 639760

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R