BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCH NAIL, LONG, 11MM RIGHT

    MDR report key: 3910626 · Received July 2, 2014

    Report

    Report Number
    0001825034-2014-05929
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    May 27, 2014
    Report Date
    June 5, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HSB
    PMA / PMN Number
    PK050118
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05928 & 05929).

    Description of Event or Problem · 1

    PATIENT REPORTED TO HAVE UNDERGONE A TROCHANTERIC NAIL PROCEDURE ON (B)(6) 2012. PATIENT FURTHER REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO PAIN, A FRACTURED NAIL AND THAT A SCREW HAD BACKED OUT. A REVIEW OF INVOICE HISTORY CONFIRMED THE DATE OF THE INITIAL SURGERY; HOWEVER, AN INVOICE COULD NOT BE LOCATED TO CONFIRM THE REVISION SURGERY DATE OR WHICH COMPONENTS WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387721 TROCH NAIL, LONG, 11MM RIGHT ROD, FIXATION HSB BIOMET ORTHOPEDICS N/A 473130

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R