BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-01432

    MDR report key: 3003087 · Received March 13, 2013

    Report

    Report Number
    2520274-2013-01432
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Report Date
    February 19, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    MNI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    PATIENT PARTICIPATED IN A STUDY FOR THE PRODUCT CHRONOS STRIP ON (B)(6) 2011. PATIENT WAS IMPLANTED WITH 100 MM X 25 MM X 3 MM CHRONOS STRIP USING 8CC BONE MARROW ASPIRATE AND 60CC LOCAL BONE. PATIENT WAS ALSO IMPLANTED WITH MATRIX IMPLANT AT L3-L4 AND L4-L5. POST OPERATIVELY, ON (B)(6) 2012, PATIENT PRESENTED WITH WORSENING LOWER BACK PAIN, BILATERAL BUTTOCKS, BILATERAL LEGS, BILATERAL NUMBNESS IN FEET, AND PAIN IN SACRUM. THIS REPORT IS FOR AN UNKNOWN MATRIX SCREW. THIS IS 7 OF 15 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106024 MNI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1