BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKTI PANGEA LOCKING CAP

    MDR report key: 2771926 · Received September 28, 2012

    Report

    Report Number
    2530088-2012-00881
    Event Type
    Injury
    Date Received
    September 28, 2012
    Report Date
    August 30, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    A PATIENT WAS IMPLANTED WITH SOLID FUSION FROM L5-S1 ON (B)(6) 2010. PATIENT DEVELOPED ADJACENT LEVEL DISC DISEASE AT L4-L5 AND WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012 WHERE SURGEON REMOVED PANGEA SCREWS AT L5 AND BOTH RODS. SURGEON PLACED USS DUAL OPENING SCREWS AT L4 AND L5, PERFORMED INTERBODY FUSION WITH T-PLIF SPACERS, IMPLANTED NEW RODS, AND CONNECTED WITH USS DONUT AND COLLARS AT L4 AND L5, AND PANGEA LOCKING CAPS AT S1. THIS REPORT IS #5 OF 10 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKTI PANGEA LOCKING CAP TI PANGEA LOCKING CAP NKB SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention LOCKING CAPS| SCREWS| RODS