BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.5MM TI MIN INVASIVE CURVED ROD 100MM RADIUS/35MM

    MDR report key: 2882394 · Received December 20, 2012

    Report

    Report Number
    8030965-2012-01625
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    November 21, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    NKB
    PMA / PMN Number
    K093668
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. ADDITIONAL NARRATIVE: INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    A PATIENT WAS IMPLANTED WITH A MATRIX CONSTRUCT AT L4-L5 ON AN UNKNOWN DATE. POST OPERATIVELY THE PATIENT PRESENTED WITH PAIN AND THE PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2012 FOR REVISION AND REMOVAL OF MATRIX HARDWARE. THIS REPORT IS #6 OF 10 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.5MM TI MIN INVASIVE CURVED ROD 100MM RADIUS/35MM 5.5MM TI MIN INVASIVE CURVED ROD 100MM RADIUS/35MM NKB SYNTHES GMBH 3787795

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention SCREWS, RODS, CAPS