BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4232610 · Received November 6, 2014

    Report

    Report Number
    2520274-2014-14565
    Event Type
    Injury
    Date Received
    November 6, 2014
    Report Date
    October 14, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR THE PLATE, PART AND LOT NUMBER UNKNOWN. IMPLANT DATE REPORTED ONLY AS (B)(6) 2013. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED A LOCKING CONDYLAR PLATE IMPLANTED ON AN UNKNOWN DATE IN (B)(6) 2013 BROKE AT THE METAPHYSEAL DIAPHYSEAL JUNCTURE BETWEEN THE STRAIGHT SHAFT PART OF THE PLATE AND THE MULTI-HOLE DISTAL END. THE PLATE WAS EXPLANTED DUE TO NONUNION AND THE BREAKAGE. THE PROCEDURE WAS REPORTED TO HAVE BEEN SUCCESSFULLY COMPLETED WITH NO DELAYS. THIS REPORT IS FOR THE UNKNOWN PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715236 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention