BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHADAPT BIOIMPLANT

    MDR report key: 1522301 · Received November 2, 2009

    Report

    Report Number
    3005147058-2009-00075
    Event Type
    Injury
    Date Received
    November 2, 2009
    Date of Event
    December 5, 2008
    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 CULTURE SAMPLE TAKEN AT THE TIME OF SURGERY IDENTIFIED "E. COLI." THIS ORGANISM IS A NON-SPORE FORMING GRAM-NEGATIVE ROD SHAPED BACTERIUM WHICH IS CATEGORIZED AS A VEGETATIVE BACTERIUM. ANY VEGETATIVE BACTERIA PRESENT DURING THE ORTHADAPT MANUFACTURING PROCESS WOULD NOT SURVIVE THE PROPRIETARY STERILIZATION PROCESS; THEREFORE, IT IS HIGHLY UNLIKELY THAT THE ORGANISM IN QUESTION COULD HAVE COME FROM THE IMPLANT. THE CASE ASSESSMENT BASED ON THE INFORMATION PROVIDED BY THE PHYSICIAN, THE PATHOLOGY REPORT AND MICROBIOLOGICAL ANALYSIS, IDENTIFIED THE LIKELY CAUSE OF THE EVENT TO BE AN INFECTIOUS PROCESS CAUSED BY EXPOSING THE WOUND/ SURGICAL REPAIR TO EXTERNAL CONTAMINATION DURING THE NON-COMPLIANT ACTIVITY. NO LINK WAS ESTABLISHED 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 FOUR WEEKS FOLLOWING ACHILLES TENDON REPAIR WITH ORTHADAPT AUGMENTATION, THE PT DEVELOPED AN ABSCESS AND CELLULITIS AT THE SURGICAL INCISIONS. THE CULTURE REPORT IDENTIFIED E. COLI, WHICH WAS TREATED WITH DEBRIDEMENT AND ANTIBIOTICS; HOWEVER, THE WOUND COMPLICATION CONTINUED POST-TREATMENT. APPROXIMATELY 17 WEEKS POST REPAIR THE GRAFT WAS REMOVED. PHYSICIAN INDICATED THE CASE WAS A REPAIR OF A PRIOR REPAIR CASE IN WHICH THE PT WAS NON-COMPLIANT IN FOLLOWING THE REHABILITATION INSTRUCTIONS, THUS RUPTURED THE REPAIR. AFTER THE RE-REPAIR THE PT WAS AGAIN NON-COMPLAINT WITH THE REHABILITATION INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHADAPT BIOIMPLANT SURGICAL MESH FTM PEGASUS BIOLOGICS, INC. OFX 2000 2000B0519A

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization