BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TRAUMA

    MDR report key: 5741594 · Received June 22, 2016

    Report

    Report Number
    0001825034-2016-02201
    Event Type
    Injury
    Date Received
    June 22, 2016
    Report Date
    September 2, 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
    NJ, 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING MULTIPLE PROCEDURES, THE SURGEON HAD TO DRILL ADDITIONAL PILOT HOLES AS A RESULT OF THE PINS BEING DIFFICULT TO DEPLOY. IT IS UNKNOWN IF A DELAY OCCURRED DURING THE PROCEDURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING MULTIPLE PROCEDURES, THE SURGEON HAD TO RE-DRILL PILOT HOLES AS A RESULT OF THE PINS BEING DIFFICULT TO DEPLOY. IT IS UNKNOWN IF A DELAY OCCURRED DURING THE PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397047 UNKNOWN TRAUMA PIN, FIXATION OVZ BIOMET TRAUMA N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention