BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI HARD ROD 50MM

    MDR report key: 3200084 · Received July 1, 2013

    Report

    Report Number
    2520274-2013-03963
    Event Type
    Injury
    Date Received
    July 1, 2013
    Report Date
    June 5, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    PMA / PMN Number
    K090605
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL CODES: KWP, KWQ, MNH, MNI. IMPLANT DATE REPORTED AS (B)(6) 2008. 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

    PATIENT UNDERWENT POSTERIOR LUMBAR FUSION AT L4-L5 IN (B)(6) 2008. PATIENT DEVELOPED CRANIAL ADJACENT LEVEL DISC DISEASE AT L2-L4. PATIENT WAS RETURNED TO O.R. ON (B)(6) 2013 FOR REMOVAL OF ALL HARDWARE. PATIENT WAS REVISED TO SYNTHES USS DUAL OPENING AT THE L2-L5 LEVELS. REVISION WAS COMPLETED WITH NO ISSUES. THIS REPORT IS 1 OF 11 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299201 6.0MM TI HARD ROD 50MM NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention