BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHADAPT BIOIMPLANT

    MDR report key: 1522296 · Received November 2, 2009

    Report

    Report Number
    3005147058-2009-00070
    Event Type
    Injury
    Date Received
    November 2, 2009
    Date of Event
    March 1, 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

    THE CASE WAS REPORTED TO THE PEGASUS BIOLOGICS, INC. APPROXIMATELY SIX MONTHS AFTER THE EVENT. MULTIPLE ATTEMPTS WERE MADE TO VERIFY THE REPORT AND OBTAIN CASE INFORMATION (INCLUDING MANUFACTURING LOT OF THE DEVICE); HOWEVER, THESE ATTEMPTS WERE UNSUCCESSFUL. ADDITIONALLY, THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. 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

    PT EXPERIENCED PAIN AND REDNESS POST POSTERIOR TIBIALIS REPAIR WITH ORTHADAPT AUGMENTATION; GRAFT WAS EXPLANTED APPROXIMATELY SIX MONTHS POST-REPAIR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization