BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHADAPT BIOIMPLANT

    MDR report key: 1522227 · Received November 2, 2009

    Report

    Report Number
    3005147058-2009-00029
    Event Type
    Injury
    Date Received
    November 2, 2009
    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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CASE WAS PERFORMED BY EXCISING THE PLANTAR FIBROMA AND THEN USING ORTHADAPT TO COVER THE PLANTAR FASCIA DEFECT. PHYSICIAN INDICATED PT'S SYMPTOMS WERE NOT RELATED TO THE ORTHADAPT BIOIMPLANT BUT FROM FIBROSIS CAUSED BY THE HEALING PROCESS; GRAFT REPORTEDLY EXPLANTED DUE TO PT REQUEST. THE MFG LOT # OF THE DEVICE WAS NOT PROVIDED. THE MFR OF THE DEVICE AT THE TIME WAS PEGASUS BIOLOGICS INC. SYNOVIS ORTHOPEDIC & WOUNDCARE INC IS THE REPORTING COMPANY FOR THE EVENT. THE EVENT OCCURRED PRIOR TO SYNOVIS ACQUIRING PEGASUS BIOLOGICS.

    Description of Event or Problem · 1

    PT EXPERIENCED PLANTAR INDURATION AND HARDENING APPROXIMATELY SIX TO EIGHT WEEKS POST PLANTAR FASCIA REPAIR WITH ORTHADAPT AUGMENTATION AFTER FIBROMA EXCISION. THE GRAFT WAS EXPLANTED APPROXIMATELY EIGHT WEEKS POST REPAIR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization