BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHADAPT BIOIMPLANT

    MDR report key: 1480341 · Received September 18, 2009

    Report

    Report Number
    3005147058-2009-00009
    Event Type
    Injury
    Date Received
    September 18, 2009
    Date of Event
    April 6, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN. SAMPLE OF THE DISCHARGE MATERIAL WAS EVALUATED: PATHOLOGY LAB INDICATED PRESENCE OF CARTILAGE MATERIALS WHICH COULD BE REMNANTS FROM THE SURGICAL PROCEDURE. NO GRAFT MATERIAL WAS PRESENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) INDICATED 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

    APPROX SEVEN WEEKS AFTER THE REPAIR (REVISION) OF LEFT ROTATOR CUFF RUPTURE WITH ORTHADAPT AUGMENTATION, THE PT HAD SWELLING AT THE SURGICAL INCISION. AFTER MAKING A SMALL CUT AND PRESSING ON THE AREA, THICK MATERIAL DISCHARGE WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHADAPT BIOIMPLANT SURGICAL MESH FTM PEGASUS BIOLOGICS, INC. OFX 1000 1000B0818A

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization ADHESIONS AND| MANIPULATION UNDER ANESTHESIA LEFT SHOULDER| REVISION ACROMIOPLASTY| DIAGNOSTIC AND OPERATIVE ARTHOSCOPY WITH LYSIS OF