BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7/3.5MM LCP ANTEROLATERAL DISTAL TIBIA PL/13H/R/232MM

    MDR report key: 2872589 · Received December 13, 2012

    Report

    Report Number
    2520274-2012-03944
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 15, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K092812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    SYNTHES WAS NOTIFIED: PATIENT WAS IMPLANTED ON AN UNKNOWN DATE WITH 2 PLATES AND SCREWS. IT WAS DISCOVERED ON AN UNKNOWN DATE THE PLATE WAS BROKEN AND PATIENT HAD A NONUNION. PATIENT WAS RETURNED TO OPERATING ROOM ON (B)(6) 2012, FOR HARDWARE REMOVAL. PATIENT HAD ELEVATED INFECTION LEVELS, PATIENT WAS NOT REVISED TO NEW HARDWARE; RUNNING TESTS FOR THE INFECTION, NO HARDWARE WILL BE RETURNED. THIS IS 1 OF 26 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.7/3.5MM LCP ANTEROLATERAL DISTAL TIBIA PL/13H/R/232MM LCP ANTEROLATERAL DISTAL TIBIA PLATE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention PLATES, SCREWS