BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2884912 · Received December 7, 2012

    Report

    Report Number
    2520274-2012-03676
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. 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

    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 (R/A) PROCEDURE, IMPLANTED A COMPETITORS RETROGRADE NAIL. THIS IS 10 OF 12 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention CONDYLAR PLATE X 1| SCREW X 10