BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPHERX DEFORMITY SYSTEM

    MDR report key: 4169043 · Received July 25, 2014

    Report

    Report Number
    2031966-2014-00049
    Event Type
    Malfunction
    Date Received
    July 25, 2014
    Date of Event
    June 19, 2014
    Report Date
    July 25, 2014
    Manufacturer
    NUVASIVE, INC.
    Product Code
    NKB
    PMA / PMN Number
    K092287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL OF THE FRACTURED SURFACE OF THE BONE SCREW SUGGESTS THERE WAS A CYCLICAL FATIGUE FAILURE. REVIEW OF THE DEVICE HISTORY RECORDS NOTES NO MATERIAL NON-CONFORMANCES OR MFG ERRORS THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS MODE OF FAILURE. IT IS UNK IF THE PT COMPLIED WITH POST-OPERATIVE CARE INSTRUCTIONS, BUT THE PT HAD PSEUDARTHROSIS ADN WAS RECENTLY INVOLVED IN A MVA. THE CONTRIBUTING FACTORS TO THE FATIGUE FAILURE ARE THE PT'S MVA, PSEUDARTHROSIS, AND TWO YEAR DURATION TO FAILURE, THOUGH IT IS INCONCLUSIVE WHICH DIRECTLY CAUSED THE SCREW FRACTURE. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    PT RECEIVED A L4-L5 POSTEROLATERAL FUSION (PLF) WITH BILATERAL PEDICLE SCREWS AND ROD INSTRUMENTATION IN (B)(6) 2012. IN 2014 THE PHYSICIAN CONFIRMED THAT THE PT HAD PSEUDARTHROSIS. PT PRESENTED POST MOTOR VEHICLE ACCIDENT (MVA) WITH EXACERBATED BACK PAIN. THESE CONDITIONS PROMPTED A PLANNED REVISION SURGERY. DURING THE REMOVAL OF ALL HARDWARE IN A PT, A FRACTURED SPHERX DEFORMITY PEDICLE SCREW WAS DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435808 SPHERX DEFORMITY SYSTEM SPINAL PEDICLE SCREW SYSTEM NKB NUVASIVE, INC. 8455545 JP4030

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention