BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-04243

    MDR report key: 3221567 · Received July 11, 2013

    Report

    Report Number
    2520274-2013-04243
    Event Type
    Injury
    Date Received
    July 11, 2013
    Report Date
    June 20, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SYNTHES (B)(4) THAT THE PATIENT HAD AN LC-DC (LIMITED CONTACT - DYNAMIC COMPRESSION) 10 HOLE NARROW 5.4MM, MEDICAL GRADE, 316L STAINLESS STEEL PLATE AND AN UNKNOWN NUMBER OF SCREWS IMPLANTED FOR A RIGHT ARM FRACTURE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4). THIS REPORT IS ON THE UNKNOWN PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319898 JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention