BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTIMESH

    MDR report key: 1456897 · Received August 25, 2009

    Report

    Report Number
    2135156-2009-00004
    Event Type
    Other
    Date Received
    August 25, 2009
    Date of Event
    June 25, 2009
    Report Date
    August 25, 2009
    Manufacturer
    SPINEOLOGY, INC.
    Product Code
    EZX
    PMA / PMN Number
    K014200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN IMPERFECTLY PLACED AN OPTIMESH DEVICE IN THE L4 VERTEBRAL BODY IN A PT WITH A PREVIOUS L4-L5 INTERBODY INFUSION (INCLUDING PEDICLE SCREWS FROM A DIFFERENT MANUFACTURER). UPON RE-INJURY, THE PT DEVELOPED RADICULAR PAIN AND NUMBNESS. ONE OF THE PEDICLE SCREWS AT L4 HAD PULLED OUT AND THE VERTEBRAL BODY PARTIALLY COLLAPSED. MRI SHOWED THAT THE SPINAL CANAL WAS 50% COMPROMISED AT L4. LOOSE BONE FRAGMENTS IN THE CANAL WERE NOTED. PT UNDERWENT REVISION SURGERY AND THE OPTIMESH DEVICE WAS CUT BY THE SURGEON CONTRARY TO RECOMMENDATION. THE REVISION SURGERY WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIMESH SURGICAL MESH EZX EZX SPINEOLOGY, INC. OPTIMESH 1500 S08009

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PEDICLE SCREWS| RODS (MANUFACTURER UNK)