BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHADAPT BIOIMPLANT

    MDR report key: 1480349 · Received September 18, 2009

    Report

    Report Number
    3005147058-2009-00012
    Event Type
    Injury
    Date Received
    September 18, 2009
    Date of Event
    March 3, 2009
    Report Date
    September 1, 2009
    Manufacturer
    PEGASUS BIOLOGICS, INC.
    Product Code
    FTL
    PMA / PMN Number
    K071065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CORRECTIVE SURGERIES (GANGLION CYST REMOVAL; TENDO ACHILLES LENGTHENING; GLEICH CALCANEAL OSTEOTOMY; EVANS CALCANEAL OSTEOTOMY WITH ALLOGENIC BONE GRAFT; COTTON OSTEOTOMY WITH BONE GRAFT) WERE DONE DURING TIBIALIS POSTERIOR TENDON REPAIR (RIGHT FOOT). THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. AS A RESULT, TESTING COULD NOT BE PERFORMED. CAUSE OF THE EVENT IS UNK AT THIS TIME. 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

    SWELLING AROUND THE INCISIONAL WOUND APPROXIMATELY SEVEN WEEKS POST TIBIALIS POSTERIOR TENDON REPAIR WITH ORTHADAPT AUGMENTATION. THE SWOLLEN AREA WAS OPENED, DRAINED AND DEBRIDED AND THE GRAFT WAS REMOVED APPROXIMATELY 12 WEEKS POST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHADAPT BIOIMPLANT SURGICAL MESH FTL PEGASUS BIOLOGICS, INC. OFX 2750 2750B0721B

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization