BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM LCP CURVED CONDYLAR PLATE 10 HOLE/242MM-R

    MDR report key: 2872653 · Received December 7, 2012

    Report

    Report Number
    3003506883-2012-00386
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    KTT
    PMA / PMN Number
    K041911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES.

    Description of Event or Problem · 1

    PT WAS IMPLANTED WITH A LCP CURVED CONDYLAR PLATE AND SCREWS ON (B)(6) 2012. ON AN UNK DATE, PT HAD X-RAYS PERFORMED, REVEALING A PLATE THAT WAS BROKEN JUST SUPERIOR TO THE KNEE (DISTAL FEMUR). PT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012 FOR REMOVAL OF HARDWARE DUE TO NON-UNION AND BROKEN PLATE. THE SURGEON PERFORMED A REAMER/IRRIGATOR/ASPIRATOR (RIA) PROCEDURE, IMPLANTED A COMPETITORS RETROGRADE NAIL. THIS IS 1 OF 12 REPORTS FOR THIS EVENT. `

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5MM LCP CURVED CONDYLAR PLATE 10 HOLE/242MM-R CURVED CONDYLAR PLATE KTT SYNTHES ELMIRA 6310743

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention SCREW X 11