BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.2MM TI CLICK'X PEDICLE SCR PREASSEMBLED

    MDR report key: 1020348 · Received March 27, 2008

    Report

    Report Number
    1719045-2008-00025
    Event Type
    Injury
    Date Received
    March 27, 2008
    Report Date
    February 29, 2008
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    MNH
    PMA / PMN Number
    K992739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.

    Description of Event or Problem · 1

    PT UNDERWENT PLIF PROCEDURE WITH INSTRUMENTATION AND INTERBODY CAGES L3-L5, POSTEROLATERAL BONE GRAFT & AUTOGENOUS BONE GRAFT FROM RT ILIAC CREST. POST-OP X-RAY NOTED L3-L4 NOT HEALED & SLIPPING FORWARD. SURGEON BELIEVES PT IS EXPERIENCING NEURAL IMPINGEMENT FROM RT SIDE NEURAL FORAMEN, WHERE SHE HAS A SPONDYLOLISTHESIS (GRADE II) DUE TO THE NONUNION. RT L3 SCREW NOTED TO BE DISSOCIATED FROM CAP. UNIT WAS REMOVED & REPLACED WITH 7MM SCREW. PT DIAGNOSED WITH PSEUDOARTHROSIS, RADICULAR PAIN. REVISION FOR HARDWARE REMOVAL, REPEAT DECOMPRESSION L3-L4, REDUCTION SPONDYLOLISTHESIS, REMOVAL & REAPPLICATION OF INTERBODY CAGES & POSTEROLATERAL PEDICLE SCREW INSTRUMENTATION L3-L5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.2MM TI CLICK'X PEDICLE SCR PREASSEMBLED CLICK'X PREASSEMBLED PEDICLE SCREWS MNH SYNTHES MONUMENT NA 1383244

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INTERBODY CAGES| BONE GRAFT