BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHADAPT BIOIMPLANT

    MDR report key: 1522264 · Received November 2, 2009

    Report

    Report Number
    3005147058-2009-00047
    Event Type
    Injury
    Date Received
    November 2, 2009
    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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT COULD NOT BE VERIFIED EVENT THOUGH MULTIPLE REQUESTS FOR INFORMATION WERE MADE TO PHYSICIAN. ADDITIONALLY, THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION, THUS TESTING COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) INDICATED THE DEVICE IDENTIFIED IN THIS REPORT MET ALL MANUFACTURING REQUIREMENTS. BECAUSE THE EVENT COULD NOT BE VERIFIED BY THE MANUFACTURER, THE CAUSE OF THE (POTENTIAL) EVENT COULD NOT BE DETERMINED. 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

    CASE WAS REPORTED AS AN EXPLANT APPROXIMATELY SIX WEEKS POST ACHILLES TENDON REPAIR USING ORTHADAPT AUGMENTATION DUE TO INFECTION; HOWEVER, THE EVENT COULD NOT BE VERIFIED EVENT THOUGH MULTIPLE REQUESTS FOR INFORMATION WERE MADE TO PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHADAPT BIOIMPLANT SURGICAL MESH FTM PEGASUS BIOLOGICS, INC. OFX 2500 2500A0813B

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization