BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHADAPT BIOIMPLANT

    MDR report key: 1522273 · Received November 2, 2009

    Report

    Report Number
    3005147058-2009-00053
    Event Type
    Injury
    Date Received
    November 2, 2009
    Date of Event
    June 6, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE CASE INFORMATION PROVIDED BY THE SURGEON, INCLUDING OPERATIVE AND PATHOLOGY REPORTS, THE REPORTED CASE IS LIKELY DUE TO WOUND COMPLICATIONS AND INFECTION; THERE IS NO IDENTIFIED LINK BETWEEN THE REPORTED EVENT AND 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. 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

    APPROXIMATELY EIGHT TO TEN WEEKS POST ACHILLES TENDON REPAIR WITH ORTHADAPT AUGMENTATION, THE PATIENT DEVELOPED PINHOLE DRAINAGE AT THE REPAIR SITE. CULTURE SAMPLES WERE NEGATIVE FOR GROWTH. AN MRI INDICATED A POSSIBLE (SEROMA OR STERILE) ABSCESS. APPROXIMATELY 15 WEEKS POST REPAIR, THE BIOIMPLANT WAS REMOVED; THE REPORTED SYMPTOMS EVENTUALLY SUBSIDED WITH WOUND CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHADAPT BIOIMPLANT SURGICAL MESH FTM PEGASUS BIOLOGICS, INC. OFX 2750 2750A0820B

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization