BEUDAMED
    FDA Adverse Event Other Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 2543036 · Received April 16, 2012

    Report

    Report Number
    3004485144-2012-00016
    Event Type
    Other
    Date Received
    April 16, 2012
    Date of Event
    March 28, 2012
    Report Date
    April 16, 2012
    Manufacturer
    LANX, INC
    Product Code
    MNI
    PMA / PMN Number
    071877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD CODE: NO TESTING METHODS PERFORMED (RELATED DEVICE WAS NOT RETURNED TO MFR). LABELING EVAL PERFORMED. THE IFU INDICATES SPINOUS PROCESS FRACTURE AS A POSSIBLE COMPLICATION. THE IFU ALSO CONTAINS WARNINGS AGAINST EXCESSIVE BONE REMOVAL AND CORRECT IMPLANT SIZING IN ORDER TO PREVENT COMPLICATIONS OF BONE FRACTURE. RESULTS CODE: NO RESULTS AVAILABLE SINCE NO EVAL PERFORMED (RELATED DEVICE WAS NOT RETURNED TO MFR). CONCLUSIONS CODE: KNOWN INHERENT RISK OF PROCEDURE. WHILE IT IS NOT BELIEVED THAT THE INTERSPINOUS PROCESS FIXATION DEVICE CONTRIBUTED TO THIS EVENT, IT CANNOT BE ABSOLUTELY CONCLUDED THAT IT DID NOT.

    Description of Event or Problem · 1

    THE PT UNDERWENT REVISION SURGERY TO ADDRESS A FRACTURED SPINOUS PROCESS (L4 VERTEBRAE). THE ORIGINAL SPINOUS PROCESS FIXATION DEVICE WAS REMOVED AND REPLACED WITH PEDICLE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX SPINAL FIXATION SYSTEM INTERSPINOUS PROCESS SPINAL SYSTEM MNI LANX, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention