BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTIMESH

    MDR report key: 2556058 · Received February 7, 2012

    Report

    Report Number
    2135156-2012-00001
    Event Type
    Other
    Date Received
    February 7, 2012
    Date of Event
    January 1, 2010
    Report Date
    February 7, 2012
    Manufacturer
    SPINEOLOGY, INC.
    Product Code
    FTL
    PMA / PMN Number
    K014200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION CONTAINED IN THIS REPORT IS BEING PROVIDED TO FDA TO COMPLY WITH MEDICAL DEVICE REPORTING REGULATIONS AND IS BASED ON INFORMATION SUBMITTED BY OTHERS THAT MAY NOT BE FACTUALLY CORRECT.

    Description of Event or Problem · 1

    FDA NOTIFIED SPINEOLOGY OF A VOLUNTARY REPORT OF A PRODUCT ISSUE. THIS WAS THE FIRST TIME SPINEOLOGY BECAME AWARE OF THIS EVENT. A PATIENT REPORTED TO THE AGENCY THAT A 3 LEVEL LUMBAR FUSION REOPERATION WAS REQUIRED AND 3 OPTIMESH AND 3 ASPEN (LANX) DEVICES WERE REMOVED. THE FULL COMPLAINT IS LISTED IN VOLUNTARY REPORT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIMESH SURGICAL MESH FTL SPINEOLOGY, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention LANX| ASPEN DEVICE| ASPEN PLATE