BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI SOFT ROD 50MM

    MDR report key: 2061239 · Received April 11, 2011

    Report

    Report Number
    2530088-2011-00116
    Event Type
    Injury
    Date Received
    April 11, 2011
    Report Date
    March 30, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MNH
    PMA / PMN Number
    K992739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE. ADDITIONAL INFO HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    PT IMPLANTED WITH CLICK'X HARDWARE AT L4-L5 IN (B)(6) 2005. HARDWARE WAS REMOVED ON (B)(6) 2011 TO REPAIR AN ADJACENT LEVEL ISSUE WITH DISC DEGENERATION. PT REVISED TO HARDWARE AT L3-L4. THERE WAS NO ISSUE WITH THE CLICK'X HARDWARE. HARDWARE WAS ONLY REMOVED TO REPAIR ADJACENT LEVEL. THIS IS THE 2ND OF 14 REPORTS SUBMITTED ON THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCREWS| LOCKING CAPS| 3D HEADS| RODS