BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ORTHOSORB PIN

    MDR report key: 6075470 · Received November 3, 2016

    Report

    Report Number
    0001825034-2016-04370
    Event Type
    Injury
    Date Received
    November 3, 2016
    Report Date
    October 6, 2016
    Manufacturer
    BIOMET TRAUMA
    Product Code
    OVZ
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE PIN FRACTURED INTO THE PATIENT'S WOUND. THE SURGEON WAS UNSURE IF ALL PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING K-WIRE WITHOUT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727798 UNKNOWN ORTHOSORB PIN PIN, FIXATION OVZ BIOMET TRAUMA N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention| S