BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-02481

    MDR report key: 3102581 · Received May 9, 2013

    Report

    Report Number
    2520274-2013-02481
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IT WAS REPORTED PATIENT WAS IMPLANTED WITH DEVICE APPROXIMATELY 18 MONTHS AGO. 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. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SALES CONSULTANT: PROCEDURE WAS PERFORMED ON PATIENT TO REMOVE THE MATRIXRIB SYSTEM BECAUSE PATIENT'S CHRONIC CHEST WALL AND SHOULDER PAIN. PATIENT WAS IMPLANTED WITH THE MATRIXRIB SYSTEM APPROXIMATELY EIGHTEEN MONTHS AGO. IT WAS REPORTED THE SALES CONSULTANT WAS UNABLE TO RETRIEVE OR ACCOUNT FOR THE PARTS, AS THEY HAD ALREADY BEEN GIVEN TO PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN UNKNOWN PLATE. THIS IS 1 OF 2 DEVICES FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203209 HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention