BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI 12-POINT NUT-11MM

    MDR report key: 3201214 · Received July 2, 2013

    Report

    Report Number
    2520274-2013-03995
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 4, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    SURGEON PERFORMED A L4-S1 LUMBAR FUSION WITH THE UNIVERSAL SPINE SYSTEM (USS) DUAL OPENING AND TRANSFORAMINAL POSTERIOR LUMBAR INTERBODY FUSION (T-PLIF) MTF ALLOGRAFT INTERBODY FUSION ON (B)(6) 2013. THE PATIENT RETURNED WITH COMPLAINTS OF PAIN. DOCTOR FOUND ON IMAGING STUDIES THAT THE L5-S1 T-PLIF SPACER HAD MIGRATED POSTERIORLY OUT OF THE DISC SPACE. HE PERFORMED THE REVISION ON (B)(6) 2013. HE REMOVED THE RODS AND THEN REMOVED THE MIGRATED T-PLIF. HE REPLACED THE USS DO SCREWS WITH LARGER DIAMETER SCREWS AT L4, L5, AND S1. HE REPLACED THE MTF ALLOGRAFT T-PLIF AT L5-S1. DOCTOR PLACED THE RODS AND PUT IN ILIAC SCREWS. THE FINAL USS DUAL OPENING CONSTRUCT IS FROM L4-ILIUM. THIS IS REPORT 15 OF 15 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301533 TI 12-POINT NUT-11MM NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention