BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHADAPT BIOIMPLANT

    MDR report key: 1522234 · Received November 2, 2009

    Report

    Report Number
    3005147058-2009-00023
    Event Type
    Injury
    Date Received
    November 2, 2009
    Date of Event
    January 24, 2008
    Report Date
    October 19, 2009
    Manufacturer
    PEGASUS BIOLOGICS, INC.
    Product Code
    FTM
    PMA / PMN Number
    K071065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORTHADAPT BIOIMPLANT WAS USED OFF-LABEL IN AN ATFL/CFL REPLACEMENT. ORTHADAPT IS NOT INDICATED FOR THIS USE. BASED ON THE INFORMATION PROVIDED BY THE COMPLAINANT, OPERATIVE NOTES AND PATHOLOGY REPORT, THERE IS NO INDICATION THAT THE INFLAMMATORY RESPONSE (GRANULOMA FOREIGN BODY REACTION) AND TENOSYNOVITIS OF THE PERONEAL TENDON ARE RELATED TO THE GRAFT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) INDICATED THE DEVICE IDENTIFIED IN THIS REPORT MET ALL MANUFACTURING REQUIREMENTS. THE MANUFACTURER OF THE DEVICE AT THE TIME WAS PEGASUS BIOLOGICS, INC.

    Description of Event or Problem · 1

    FOLLOWING AN ATFL/CFL REPLACEMENT (INCLUDED FIXATING THE ORTHADAPT GRAFT TO BONE), THE PATIENT WAS NOTED TO HAVE A FOREIGN BODY REACTION WITH GRANULOMA FORMATION AND TENOSYNOVITIS OF THE PERONEAL TENDON (ONSET DATE UNKNOWN) DURING EXPLORATORY SURGERY APPROXIMATELY FIVE MONTHS POST-SURGERY. PHYSICIAN DISSECTED AND REMOVED THE GRANULOMATOUS MASS, EXPOSING THE ORTHADAPT GRAFT. PART OF THE GRAFT WAS STILL ANCHORED TO THE CALCANEUS AND APPEARED TO BE IN ITS NORMAL (UNINCORPORATED) STATE; THE REMAINDER OF THE GRAFT APPEARED TO HAVE INCORPORATED. THE INCORPORATED GRAFT WAS NOT REMOVED. THE ATFL WAS NOTED TO BE INTACT WHILE THE CFL LIGAMENT AND PERONEAL TENDON WERE TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHADAPT BIOIMPLANT SURGICAL MESH FTM PEGASUS BIOLOGICS, INC. OFX 2500 POR 070104-01R

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization