BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHADAPT BIOIMPLANT

    MDR report key: 1559628 · Received December 11, 2009

    Report

    Report Number
    3005147058-2009-00144
    Event Type
    Injury
    Date Received
    December 11, 2009
    Date of Event
    December 6, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN PERFORMED COBLATION THERAPY WITH TOPAZ ON THE POSTERIOR TIBIALIS TENDON TO DEBRIDE A NONVIABLE/ THICKENED SECTION. THE TENDON RUPTURE WAS RE-APPROXIMATED WITH 3-0 VICRYL SUTURE FOLLOWED BY ORTHADAPT AUGMENTATION OVER THE TENDON SHEATH. THE CASE ASSESSMENT, BASED ON THE PROVIDED INFORMATION, COULD NOT DETERMINE THE SPECIFIC CAUSE OF THE EVENT; HOWEVER, THE COMBINATION OF POOR NATIVE TISSUE COBLATED WITH TOPAZ, METHOD OF BIOIMPLANT FIXATION AND INFECTION COULD NOT BE RULED OUT AS POSSIBLE CONTRIBUTORS TO THE EVENT. PHYSICIAN INDICATED THAT WHEN THE BIOIMPLANT WAS REMOVED, THE NATIVE TISSUE WAS HEALED. THE MANUFACTURER OF THE DEVICE AT THE TIME WAS PEGASUS BIOLOGICS, INC.

    Description of Event or Problem · 1

    PATIENT DEVELOPED EDEMA ON THE LEFT ANKLE APPROXIMATELY THREE MONTHS POST POSTERIOR TIBIALIS TENDON REPAIR WITH TOPAZ DEBRIDEMENT AND TENDON SHEATH AUGMENTATION WITH ORTHADAPT. TWO WEEKS LATER, 15 CC OF FLUID WAS ASPIRATED. ONE WEEK LATER, EXPLORATORY SURGERY REVEALED THE NATIVE TISSUE WAS HEALED AND SUBSEQUENTLY, THE BIOIMPLANT WAS REMOVED.

    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 61 YR Hospitalization LEFT| TOPAZ - DEBRIDEMENT OF THE LEFT POSTERIOR TIBIALIS| TENOSYNOVITIS OF THE POSTERIOR TIBIALIS TENDON| TENDON