BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHADAPT BIOIMPLANT

    MDR report key: 1522241 · Received November 2, 2009

    Report

    Report Number
    3005147058-2009-00032
    Event Type
    Injury
    Date Received
    November 2, 2009
    Date of Event
    March 31, 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

    THE PHYSICIAN REPORTED THE POST-OPERATIVE CULTURE FINDINGS WERE NEGATIVE; HOWEVER, BASED ON THE AVAILABLE CASE INFORMATION AND FEEDBACK FROM THE PHYSICIAN, THE LIKELY CAUSE OF THE EVENT IS DUE TO INFECTION CAUSED BY CONTAMINATION OF THE OPEN WOUND. 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 10 WEEKS POST ANTERIOR TIBIALIS RUPTURE REPAIR WITH ORTHADAPT AUGMENTATION, THE OPERATIVE SITE APPEARED TO BE INFECTED; AS A RESULT THE PATIENT WAS PLACED ON ANTIBIOTICS. APPROXIMATELY 12 WEEKS POST-REPAIR, THE DISTAL SURGICAL INCISION WAS OPENED AND A WOUND DRESSING WAS APPLIED. APPROXIMATELY 24 WEEKS POST-REPAIR THE WOUND DRESSING WAS REMOVED; IT APPEARED THAT THE GRAFT WAS LOOSE AND THAT THERE WAS FLUID ACCUMULATION, THE GRAFT WAS EXPLANTED AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHADAPT BIOIMPLANT SURGICAL MESH FTM PEGASUS BIOLOGICS, INC. OFX 2750 POR 061218-01

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization