BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONDYLAR PLATE

    MDR report key: 2792661 · Received October 16, 2012

    Report

    Report Number
    2520274-2012-02318
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    September 20, 2012
    Report Date
    September 20, 2012
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS DEVICE WAS NOT RETURNED AND PART NUMBER AND LOT NUMBER WERE NOT PROVIDED.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH NON-UNION FEMUR FRACTURE. SURGEON PERFORMED A LOCKING CONDYLAR PLATE AND SCREW REMOVAL; PLATE WAS BROKEN AT THE DISTAL PORTION PRE-OPERATIVELY. THIS IS THE FIRST OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONDYLAR PLATE CONDYLAR PLATE HRS

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention COMPETITOR ROD