BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3781989 · Received April 30, 2014

    Report

    Report Number
    2520274-2014-11139
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    April 2, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF EVENT IS UNKNOWN. THIS REPORT IS FOR ONE UNKNOWN MATRIXRIB PLATE. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. 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)(69) AS FOLLOWS: IT WAS REPORTED THAT A MATRIXRIB PLATE SNAPPED SUPERIOR ANTERIOR MEDIASTINUM (SAM) ONE MONTH POST OPERATIVELY. THIS REPORT IS FOR ONE UNKNOWN MATRIXRIB PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260677 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1