BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHADAPT BIOIMPLANT

    MDR report key: 1522271 · Received November 2, 2009

    Report

    Report Number
    3005147058-2009-00052
    Event Type
    Injury
    Date Received
    November 2, 2009
    Date of Event
    July 23, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) INDICATED THE DEVICE IDENTIFIED IN THIS REPORT MET ALL MANUFACTURING REQUIREMENTS. THE CASE ASSESSMENT BASED ON THE PROVIDED INFORMATION IDENTIFIED THE LIKELY CAUSE OF THE EVENT TO BE THE CONDITION OF NATIVE TISSUE; A LINK BETWEEN THE REPORTED EVENT AND THE GRAFT WAS NOT IDENTIFIED DURING THE CASE ASSESSEMENT. 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 PAIN AND DECREASED RANGE OF MOTION APPROXIMATELY 11 WEEKS POST ROTATOR CUFF REPAIR WITH ORTHADAPT AUGMENTATION. THE GRAFT WAS EXPLANTED APPROXIMATELY SIX MONTHS POST IMPLANT. PHYSICIAN REPORTED THAT THE EVENT WAS DUE TO THE (NON-VIABLE) CONDITION OF THE NATIVE TISSUE.

    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 50 YR Hospitalization