BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT SPECIFIC INSTR/PLAN KTORTHOGNATHIC KIT, TWO SPLINTS

    MDR report key: 3204642 · Received July 3, 2013

    Report

    Report Number
    2520274-2013-04073
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    PMA / PMN Number
    K103136
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ADDITIONAL CODE: MQN. 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

    RESIDENT REPORTED: THE SPLINT TO THICK AND THEY HAD TO USE THEIR OWN TO COMPLETE THE PROCEDURE. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305846 PATIENT SPECIFIC INSTR/PLAN KTORTHOGNATHIC KIT, TWO SPLINTS JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR