BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE,FIXATION,BONE

    MDR report key: 4013037 · Received August 15, 2014

    Report

    Report Number
    2520274-2014-13143
    Event Type
    Injury
    Date Received
    August 15, 2014
    Report Date
    July 22, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: UNKNOWN. THIS REPORT IS FOR AN UNKNOWN PLATE/UNKNOWN LOT. IMPLANT DATE: UNKNOWN. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE REVISION SURGERY WAS CONDUCTED ON (B)(6) 2014 DUE TO THE BREAKAGE OF THE IMPLANTED PLATE. NEW HARDWARE WAS INSERTED FOR RE-FIXATION AFTER REMOVAL OF THE BROKEN PLATE. THIS REPORT IS FOR AN UNKNOWN PLATE. THIS IS REPORT 1 OF 1 FOR (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489401 PLATE,FIXATION,BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention