BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ORTHOSORB TRAUMA

    MDR report key: 6075466 · Received November 3, 2016

    Report

    Report Number
    0001825034-2016-04372
    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

    IT WAS REPORTED DURING MULTIPLE CASES, THE PIN FRACTURED DURING USE. THE SURGEON REPORTED DIFFICULTY FINDING FRACTURED PIECES IN THE PATIENT AND SOME PIECES MAY BE RETAINED DUE TO THE COLOR OF THE PIN. SOME CASES HAVE BEEN COMPLETED USING ANOTHER DEVICE. NO FURTHER INFORMATION HAS BEEN PROVIDED REGARDING PATIENT OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726340 UNKNOWN ORTHOSORB TRAUMA PIN, FIXATION OVZ BIOMET TRAUMA N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S