BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONEXA

    MDR report key: 2160019 · Received July 13, 2011

    Report

    Report Number
    1000306051-2011-00014
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 10, 2011
    Report Date
    August 12, 2011
    Manufacturer
    LIFECELL CORPORATION
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS: QUERY OF LIFECELL COMPLAINT SYSTEM FOR ANY OTHER COMPLAINTS REPORTED AGAINST DEVICES DISTRIBUTED FROM LOT T00025. REVIEW OF DEVICE HISTORY RECORDS RESULTED IN NO REMARKABLE FINDINGS. AS OF (B)(4) 2011, THERE WERE 112 DEVICES FROM LOT T00025 DISTRIBUTED WITH NO OTHER COMPLAINTS REPORTED TO LIFECELL AGAINST THIS LOT. CONCLUSION: NO FAILURE DETECTED; DEVICE WITHIN SPECIFICATION. ACCORDING TO INTERNAL INVESTIGATION, NO FAILURE DETECTED; DEVICE MET SPECIFICATION. HOWEVER, LIFECELL HAS DETERMINED THAT THE DEVICE MAY HAVE BEEN A CONTRIBUTING FACTOR IN THE PATIENT'S INFLAMMATORY RESPONSE.

    Description of Event or Problem · 1

    THIS IS A FOLLOW-UP TO INITIAL REPORT# 1000306051-2011-0014 FILED ON (B)(6) 2011 TO INCLUDE THE RESULTS OF PATHOLOGICAL EVALUATION.

    Description of Event or Problem · 1

    LIFECELL RECEIVED FDA FORM 3500A FROM (B)(6), LIFECELL DISTRIBUTION PARTNER. THE REPORT WAS FILED BY THE USER FACILITY. IT WAS REPORTED THAT PATIENT UNDERWENT SURGERY FOR PAINFUL ANKLE WITH SYNOVITIS, INSTABILITY WITH LIGAMENTOUS DISRUPTION OF THE ANKLE AND DISTAL AVULSION FIBULAR FRACTURE, ANKLE. PATIENT DEVELOPED A CHRONIC INFECTION THAT WAS TREATED WITH VANCOMYCIN VIA PICC LINE (CULTURE RESULTS FROM THIS TIME PERIOD NOT AVAILABLE TO REPORTER). INFECTION RESOLVED BUT PATIENT CONTINUED HAVING PAIN AND INSTABILITY. PATIENT RETURNED TO OR FOR REMOVAL OF DEVICE AND SCREW 7 MONTHS LATER. FOREIGN BODY REACTION OF THE CONEXA SOFT TISSUE GRAFT THAT WAS PLACED IN THE AREA FOR THE ANTERIOR TALOFIBULAR LIGAMENT REPAIR WAS FOUND. THE DEVICE MATERIAL WAS REMOVED. PATHOLOGICAL ANALYSIS WAS PERFORMED AT THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONEXA SURGICAL MESH FTM LIFECELL CORPORATION 0204004 T00025-107

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention