BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHADAPT BIOIMPLANT

    MDR report key: 1480338 · Received September 18, 2009

    Report

    Report Number
    3005147058-2009-00008
    Event Type
    Injury
    Date Received
    September 18, 2009
    Date of Event
    February 17, 2009
    Report Date
    August 31, 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 PRODUCT WAS NOT RETURNED TO THE MFR FOR EVAL. AS A RESULT TESTING COULD NOT BE PERFORMED. CAUSE OF THE EVENT IS UNK AT THIS TIME. ADDITIONAL INFO WAS REQUESTED FROM THE PHYSICIAN; HOWEVER, NO ADDITIONAL INFO WAS PROVIDED AT THE TIME OF THIS REPORT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) INDICATED THE DEVICE IDENTIFIED IN THIS REPORT MET ALL MFG REQUIREMENTS. THE MFR 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

    A CYST WAS NOTED ON THE LATERAL ANKLE OF THE RIGHT FOOT APPROX SIX MONTHS POST LATERAL COLLATERAL LIGAMENT REPAIR WITH ORTHADAPT AUGMENTATION. BIOIMPLANT EXPLANT FOLLOWING DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHADAPT BIOIMPLANT SURGICAL MESH FTM PEGASUS BIOLOGICS, INC. OFX 1100 1100B0630C

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization