BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP LOW BEND MEDIAL DSTLTIBIA PLATE/14H/RIGHT/239MM

    MDR report key: 2810101 · Received October 31, 2012

    Report

    Report Number
    3003506883-2012-00345
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 2, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K013248
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTED APPROXIMATELY (B)(6) 2012. DHR REVIEW FOUND NOTHING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED INCIDENT. ALL PARTS FROM SUBJECT PRODUCT LOT RELEASED TO WAREHOUSE MET APPLICABLE DIMENSIONAL AND VISUAL REQUIREMENTS THROUGHOUT MANUFACTURING. NO SAMPLE RETURNED FOR PHYSICAL EVALUATION. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED APPROXIMATELY (B)(6) 2012, WITH AN LCP LOW BEND MEDIAL DISTAL PLATE. ON AN UNKNOWN DATE IT WAS DISCOVERED PATIENT HAD A NONUNION. PATIENT RETURNED TO OPERATING ROOM ON (B)(6) 2012, HARDWARE WAS REMOVED, PATIENT REVISED TO A ROD. IT WAS NOTED PATIENT WAS NON-COMPLIANT AND AMBULATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM LCP LOW BEND MEDIAL DSTLTIBIA PLATE/14H/RIGHT/239MM LCP LOW BEND MEDIAL DSTLTIBIA PLATE HRS SYNTHES ELMIRA 6792169

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR PLATE, SCREW