BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHADAPT BIOIMPLANT

    MDR report key: 1522266 · Received November 2, 2009

    Report

    Report Number
    3005147058-2009-00048
    Event Type
    Injury
    Date Received
    November 2, 2009
    Date of Event
    July 11, 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
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) INDICATED THE DEVICE IDENTIFIED IN THIS REPORT MET ALL MANUFACTURING REQUIREMENTS. BASED ON THE AVAILABLE CASE INFORMATION, CLINICAL PRESENTATION AND PATHOLOGY FINDINGS, A CORRELATION BETWEEN THE SYMPTOMS AND THE ORTHADAPT BIOIMPLANT COULD NOT BE IDENTIFIED. THE MOST LIKELY CAUSES OF THE REPORTED SYMPTOMS WERE GRANULOMATOUS REACTION TO SUTURE LIKE MATERIALS AND FIBRIN CLOT. THE MANUFACTURER OF THE DEVICE AT THE TIME WAS PEGASUS BIOLOGICS, INC. SYNOVIS ORTHOPEDIC AND WOUNDCARE, INC. IS THE REPORTING COMPANY FOR THE EVENT. THE EVENT OCCURRED PRIOR TO SYNOVIS ACQUIRING PEGASUS BIOLOGICS.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED PAIN AND SWELLING (DATE UNK) POST ANTERIOR TIBIALIS REPAIR WITH ORTHADAPT AUGMENTATION. THE GRAFT WAS EXPLANTED APPROXIMATELY 10 MONTHS POST REPAIR; AT THE TIME OF EXPLANT, SEVERAL RICE BODIES WERE NOTED AROUND THE UNWRAPPED TENDON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHADAPT BIOIMPLANT SURGICAL MESH FTM PEGASUS BIOLOGICS, INC. OFX 1000 POR 070510-01

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization