BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI COLLAR WITH COLLAR WITH GROOVES

    MDR report key: 2476956 · Received February 24, 2012

    Report

    Report Number
    2530088-2012-00090
    Event Type
    Injury
    Date Received
    February 24, 2012
    Report Date
    January 31, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MNH
    PMA / PMN Number
    K992739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    A PT WAS IMPLANTED WITH USS SYSTEM AT L4-S ON AN UNK DATE. THE PT SUBSEQUENTLY DEVELOPED ADJACENT LEVEL DISC DISEASE AT L2-L3, L3-L4. THE PT WAS RETURNED TO THE OPERATING ROOM FOR REVISION AND REMOVAL OF HARDWARE ON (B)(6) 2012. THE PT HAD SOLID FUSION FROM L4-S1. THE SURGEON REMOVED ALL HARDWARE AND REVISED THE PT WITH A NEW USS DUAL-OPENING SYSTEM AT L2-S1. THIS REPORT IS #9 OF 20 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI COLLAR WITH COLLAR WITH GROOVES TI COLLAR WITH GROOVES MNH SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention