BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI SOFT ROD 50MM

    MDR report key: 2822912 · Received November 7, 2012

    Report

    Report Number
    2530088-2012-00970
    Event Type
    Injury
    Date Received
    November 7, 2012
    Report Date
    October 9, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MNH
    PMA / PMN Number
    K992739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    PATIENT HAD A TLIF PROCEDURE ON (B)(6) 2010 AND WAS IMPLANTED WITH 4 SCREWS, 2 RODS AT L 3-4, 4-5. POST-OPERATIVELY, THE PATIENT EXPERIENCED NON-HEALING OF THE SURGICAL INCISION SITE. EXERTION RESULTS IN OPENING AND BLEEDING AT THE SITE. THE PATIENT HAS UNDERGONE EXTENSIVE TESTING AND NO INFECTION WAS FOUND. ALLERGY TESTING WAS DONE AND IS POSITIVE FOR METALS. THERE IS NO PLAN FOR REVISION AT THIS TIME. THIS IS THE # 1 OF 6 OF REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.0MM TI SOFT ROD 50MM 6.0MM SOFT ROD MNH SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCREWS, RODS