BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-02513

    MDR report key: 3111131 · Received May 14, 2013

    Report

    Report Number
    2520274-2013-02513
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    April 17, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: ADDITIONAL CLASSIFICATION CODES MNI, MNH, KWP, KWQ. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    ON AN UNKNOWN DATE IN 2008, A PATIENT WAS IMPLANTED WITH HARDWARE FROM L2-S1. PATIENT HAD SOLID FUSION AT THOSE LEVELS WITH NO ISSUES WITH THE HARDWARE. ON AN UNKNOWN DATE, THE PATIENT PRESENTED ADJACENT LEVEL DISC DISEASE AT THE L1-2 LEVEL. PATIENT UNDERWENT REVISION SURGERY. THE HARDWARE FROM THE SURGERY IN 2008 WAS REMOVED AND THE DOCTOR REPLACED IT WITH THE USS DUAL OPENING FROM T10-ILLIUM. USS VARIABLE ANGLE SCREWS WERE PLACED AT THE L2 LEVEL. THE HARDWARE REMOVED WAS THE CLICKX WITH POP ON HEADS FROM L2-L5 AND THE PANGEA AT S1. THE REVISION WAS COMPLETED WITHOUT ANY ADVERSE CONSEQUENCES FOR THE PATIENT. THIS IS REPORT 21 OF 21 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212027 NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention