BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHADAPT BIOIMPLANT

    MDR report key: 1522284 · Received November 2, 2009

    Report

    Report Number
    3005147058-2009-00061
    Event Type
    Injury
    Date Received
    November 2, 2009
    Date of Event
    August 25, 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
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE CASE INFORMATION, THE CAUSE OF THE REPORTED CASE IS LIKELY FIXATION FAILURE CAUSED BY AVASCULAR CONDITION OF THE TENDON. THIS CONDITION MAY HAVE BEEN EXACERBATED BY THE USE OF COBLATION/ABLATION PROCEDURE; THERE IS NO IDENTIFIED LINK BETWEEN THE REPORTED EVENT AND THE GRAFT. BECAUSE THE MANUFACTURING LOT AND EXPIRATION DATE OF THE DEVICE WERE NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE PERFORMED AT THE TIME OF THIS REPORT. 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 SWELLING AND PAIN ALONG THE INCISION SITE APPROXIMATELY 11 WEEKS POST PERONEAL TENDON REPAIR WITH ORTHADAPT AUGMENTATION. THE GRAFT WAS EXPLANTED FIVE DAYS LATER; INFLAMMATION WAS NOTED AT EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHADAPT BIOIMPLANT SURGICAL MESH FTM PEGASUS BIOLOGICS, INC. OFX 2750 / OFX 1000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization TOPAZ COBLATION/ABLATION