BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHADAPT BIOIMPLANT

    MDR report key: 1522277 · Received November 2, 2009

    Report

    Report Number
    3005147058-2009-00056
    Event Type
    Injury
    Date Received
    November 2, 2009
    Date of Event
    August 15, 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
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) INDICATED THE DEVICE IDENTIFIED IN THIS REPORT MET ALL MANUFACTURING REQUIREMENTS. THE CULTURE TAKEN AT FOUR WEEKS POST REPAIR IDENTIFIED AN INFECTION (KLEBSIELLA). THIS ORGANISM IS NON-SPOREFORMING GRAM-NEGATIVE ROD SHAPED BACTERIUM AND 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 KLEBSIELLA COULD HAVE COME FROM THE IMPLANT. BASED ON THE AVAILABLE CASE INFORMATION, THE PATHOLOGY REPORT AND MICROBIOLOGICAL ANALYSIS, THE REPORTED CASE IS LIKELY DUE TO AN INFECTIOUS PROCESS. AT THIS TIME, THERE IS NO EVIDENT LINK BETWEEN THE SIGNS AND SYMPTOMS THE PATIENT EXPERIENCED AND THE BIOIMPLANT. 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

    PATIENT EXPERIENCED WOUND DEHISCENCE AT TWO WEEKS AND SUBSEQUENT INFECTION (KLEBSIELLA) AT FOUR WEEKS POST REPAIR OF PERONEAL TENDON WITH ANTIBIOTICS; SUBSEQUENT CULTURES WERE NEGATIVE. SIX WEEKS POST IMPLANT, PART OF THE GRAFT WAS PROTRUDING FROM THE WOUND. THE PROTRUDING PORTION WAS EXCISED FOR ANALYSIS. TWO WEEKS LATER (APPROXIMATELY 8 WEEKS POST IMPLANT), THE GRAFT WAS REMOVED AND THE PERONEAL TENDON WAS FOUND TO BE RUPTURED. THE SURGEON REPORTED THE RUPTURE CAUSED THE GRAFT TO BE LOOSE AND THAT THIS WAS THE CAUSE OF THE SUBSEQUENT WOUND DEHISCENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHADAPT BIOIMPLANT SURGICAL MESH FTM PEGASUS BIOLOGICS, INC. OFX 1000 100B0512A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization