BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH

    MDR report key: 3212853 · Received July 9, 2013

    Report

    Report Number
    2530088-2013-01019
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 11, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE WAS IMPLANTED ON AN UNKNOWN DATE. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    PATIENT WAS PREVIOUSLY IMPLANTED WITH SPINOUS PROCESS CLAMPS AT L2-L3 ON AN UNKNOWN DATE IN 2010. PATIENT WAS RETURNED TO OR ON (B)(6) 2013 FOR REMOVAL OF CLAMPS AND FACET SCREW DUE TO NON-FUSION. PATIENT WAS REVISED TO A FULL FUSION WITH PEDICLE SCREW, RODS, TRANSCONNECTOR AND FRA FROM S1-L3. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313645 7.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH NKB SYNTHES BRANDYWINE 6612842

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention