BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAR

    MDR report key: 2802861 · Received October 24, 2012

    Report

    Report Number
    2520274-2012-02552
    Event Type
    Injury
    Date Received
    October 24, 2012
    Report Date
    August 29, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT. REPORT ORIGINALLY RECEIVED (B)(4) 2012; FURTHER EVALUATION REVEALED 43 ADDITIONAL DEVICES WITHIN THE REPORTED EVENT WHICH WERE IDENTIFIED ON (B)(4) 2012. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS DEVICE WAS NOT RETURNED AND LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT UNDERWENT REMOVAL OF RODS AND SCREWS - T12-S1. REVISION FUSION, REPAIR PSEUDOARTHROSIS L3-L4. RE-INSTRUMENTATION T12-PELVIS ON (B)(6) 2010. THIS IS #29 OF 44 REPORTS FOR THE SAME EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention RODS, SCREWS, COLLARS, NUTS