BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BROOKER TIBIAL INTERLOCKING NAIL 10MM X 35CM

    MDR report key: 2151969 · Received July 7, 2011

    Report

    Report Number
    1825034-2011-00550
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 13, 2001
    Report Date
    June 10, 2011
    Manufacturer
    BIOMET TRAUMA
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "PAIN, DISCOMFORT, OR ABNORMAL SENSATIONS DUE TO THE PRESENCE OF THE DEVICE." (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LEGAL COUNSEL THAT PATIENT UNDERWENT A PROCEDURE UTILIZING A TIBIAL NAIL IN (B)(6) 1994. SUBSEQUENTLY, THE PATIENT BEGAN TO EXPERIENCE PAIN AND A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2001 TO REMOVE THE TIBIAL NAIL. THE NAIL COULD NOT BE EXTRACTED DURING THE REVISION PROCEDURE. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BROOKER TIBIAL INTERLOCKING NAIL 10MM X 35CM ROD, FIXATION HSB BIOMET TRAUMA N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R