BEUDAMED
    FDA Adverse Event Summary report: N

    ORTHADAPT BIOIMPLANT

    MDR report key: 1491010 · Received September 18, 2009

    Report

    Report Number
    3005147058-2009-00003
    Date Received
    September 18, 2009
    Date of Event
    January 14, 2009
    Report Date
    September 1, 2009
    Manufacturer
    PEGASUS BIOLOGICS, INC.
    Product Code
    FTM
    PMA / PMN Number
    K071065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) INDICATED THAT 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

    ORTHADAPT BIOIMPLANT WAS FOUND TO BE DELAMINATED AND NOT INCORPORATED IN THE TISSUE OF THE ROTATOR CUFF TENDON, DURING DIAGNOSTIC ARTHROSCOPIC PROCEDURE OF THE SHOULDER. THE GRAFT WAS REMOVED 15 MONTHS POST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHADAPT BIOIMPLANT SURGICAL MESH FTM PEGASUS BIOLOGICS, INC. OFX 1000 1000A0827A

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization