BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTIMESH

    MDR report key: 888822 · Received August 1, 2007

    Report

    Report Number
    2135156-2007-00002
    Event Type
    Other
    Date Received
    August 1, 2007
    Date of Event
    July 1, 2007
    Report Date
    July 11, 2007
    Manufacturer
    SPINEOLOGY, INC.
    Product Code
    EZX
    PMA / PMN Number
    K014200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT FELL ANS SUSTAINED VERTEBRAL COMPRESSION FRACTURES AT L2 AND L3. SURGERY FOR AUGMENTATION WAS UNEVENTFUL. SUBSEQUENT MRI INDICATED OSTEOMYELITIS IN ONE OR BOTH LEVELS. ANTERIOR CORPECTOMY AND DEBRIDEMENT PERFORMED AT L2 AND L3. TISSUE CULTURES ARE POSITIVE FOR STAPH EPIDERMIDIS. DR INDICATED THAT THE INFECTION MAY HAVE BEEN SEEDED FROM PORT-A-CATH IN PLACE PRIOR TO INITIAL SURGERY. PT IS STABLE, ON IV ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIMESH EZX SPINEOLOGY, INC. 1500E S05016

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R LOT #038533341038| IMPLANTED WITH OPTIMESH ON| AFT (MUSCULOSKELETAL TRANSPLANT FOUNDATION)| LOT #041542121058 AND| REMOVED