BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOSORB LS 1.3MM 3 PIN KIT

    MDR report key: 5792505 · Received July 13, 2016

    Report

    Report Number
    0001825034-2016-02575
    Event Type
    Malfunction
    Date Received
    July 13, 2016
    Report Date
    June 15, 2016
    Manufacturer
    BIOMET TRAUMA
    Product Code
    OVZ
    PMA / PMN Number
    PK140625
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 3 STATES, "BENDING, FRACTURE, LOOSENING, RUBBING AND MIGRATION OF THE DEVICES CAN OCCUR AS A RESULT OF EXCESSIVE ACTIVITY, TRAUMA OR LOAD BEARING."

    Description of Event or Problem · 1

    DURING AN UNKNOWN PROCEDURE THE PIN FRACTURED. NO PATIENT INJURY OR DELAY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443881 ORTHOSORB LS 1.3MM 3 PIN KIT PIN, FIXATION OVZ BIOMET TRAUMA N/A 172230

    Patients

    Seq Age Sex Outcome Treatment
    1