BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHADAPT BIOIMPLANT

    MDR report key: 1559624 · Received December 11, 2009

    Report

    Report Number
    3005147058-2009-00132
    Event Type
    Injury
    Date Received
    December 11, 2009
    Date of Event
    August 27, 2007
    Report Date
    December 10, 2009
    Manufacturer
    PEGASUS BIOLOGICS, INC.
    Product Code
    FTM
    PMA / PMN Number
    K071065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORTHADAPT BIOIMPLANT WAS USED TO AUGMENT THE TISSUE REPAIR POST AMPUTATION. THE ORTHADAPT WAS SUTURED OVER THE BONE AND UNDERNEATH THE SOFT TISSUE. THE SURGEON NOTED THAT THE PATIENT HAD POOR NATIVE TISSUE DUE TO ADVANCED DIABETES. BASED ON THE PROVIDED CASE INFORMATION, THE OFF LABEL USE AND POOR NATIVE TISSUE LIKELY CONTRIBUTED TO THE EVENT. THE PRODUCT LOT NUMBER WAS NOT PROVIDED TO THE MANUFACTURER. THE MANUFACTURER OF THE DEVICE AT THE TIME WAS PEGASUS BIOLOGICS, INC.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SURGICAL AMPUTATION IN WHICH AN ORTHADAPT BIOIMPLANT WAS FIXATED BETWEEN THE SOFT TISSUE AND OVER THE BONE. DURING A SCHEDULED VISIT, THE PHYSICIAN NOTED THE GRAFT WAS NOT ATTACHED TO THE TISSUE, AND IT WAS SUBSEQUENTLY EXPLANTED.

    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