BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONEXA

    MDR report key: 2211843 · Received August 15, 2011

    Report

    Report Number
    1000306051-2011-00024
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 28, 2011
    Report Date
    August 15, 2011
    Manufacturer
    LIFECELL CORPORATION
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD OF EVALUATION: REVIEW OF INFORMATION REPORTED TO LIFECELL. REVIEW OF THE DEVICE HISTORY RECORDS. REVIEW OF THE LIFECELL COMPLAINT SYSTEM FOR ANY SIMILAR COMPLAINTS REPORTED TO LIFECELL AGAINST THIS LOT. RESULTS OF EVALUATION: REVIEW OF THE DEVICE HISTORY RECORD RESULTED IN NO REMARKABLE FINDINGS, WITH NO DEVIATIONS RELATED TO THE NATURE OF THIS COMPLAINT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT ROTATOR CUFF REPAIR WITH LIFECELL DEVICE AND HAD A REACTION IN THE FORM OF A HUMERAL HEAD EROSION POST-IMPLANTATION. THE DEVICE WAS NOT EXPLANTED; CULTURES WERE TAKEN BUT THE RESULTS ARE NOT AVAILABLE. THE PATIENT WILL REQUIRE REVERSE SHOULDER ARTHROPLASTRY BUT HE IS STABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONEXA SURGICAL MESH FTM LIFECELL CORPORATION 0505003 T00058-064

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention