BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHADAPT BIOIMPLANT

    MDR report key: 1480333 · Received September 18, 2009

    Report

    Report Number
    3005147058-2009-00005
    Event Type
    Injury
    Date Received
    September 18, 2009
    Date of Event
    January 15, 2009
    Report Date
    August 31, 2009
    Manufacturer
    PEGASUS BIOLOGICS, INC.
    Product Code
    FTM
    PMA / PMN Number
    K071065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORTHADAPT BIOIMPLANT WAS USED ON TOP OF THE ALLOGRAFT. THE INSTRUCTIONS FOR USE DO NOT RECOMMEND THIS TYPE OF PROCEDURE DUE TO THE LACK OF VASCULARITY. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) INDICATED THE DEVICE IDENTIFIED IN THIS REPORT MET ALL MFG REQUIREMENTS. THE MFR 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

    SWELLING FIVE TO SIX MONTH POST QUAD TENDON RECONSTRUCTION WITH ALLOGRAFT AND ORTHADAPT OVERLAY. ASPIRATION REVEALED A PUS-LIKE FLUID. CULTURE WAS NEGATIVE. GRAFT WAS REMOVED 6.5 MONTHS POST IMPLANT. NATIVE TISSUE WAS HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHADAPT BIOIMPLANT SURGICAL MESH FTM PEGASUS BIOLOGICS, INC. OFX 2000 2000B0206A

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization