BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHADAPT BIOIMPLANT

    MDR report key: 1522298 · Received November 2, 2009

    Report

    Report Number
    3005147058-2009-00072
    Event Type
    Injury
    Date Received
    November 2, 2009
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL ATTEMPTS WERE MADE TO 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; LOT NUMBER IS UNK. THE CASE ASSESSMENT BASED ON THE PROVIDED INFORMATION IDENTIFIED THE LIKELY CAUSE OF THE EVENT TO BE WOUND COMPLICATIONS; A LINK BETWEEN THE REPORTED EVENT AND THE GRAFT WAS NOT IDENTIFIED DURING THE CASE ASSESSMENT. 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 WOUND DEHISCENCE, ERYTHEMA AND DRAINAGE FOLLOWING AN ACUTE ACHILLES TENDON REPAIR WITH ORTHADAPT AUGMENTATION. A SKIN FLAP FAILED AND THE WOUND DID NOT CLOSE; THE GRAFT WAS SUBSEQUENTLY REMOVED. THE NATIVE TISSUE WAS REPORTED TO BE HEALED.

    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 55 YR Hospitalization