BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHADAPT BIOIMPLANT

    MDR report key: 1522229 · Received November 2, 2009

    Report

    Report Number
    3005147058-2009-00028
    Event Type
    Injury
    Date Received
    November 2, 2009
    Date of Event
    March 10, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FEMALE WITH A LEFT CHRONIC MID-SUBSTANCE ACHILLES RUPTURE UNDERWENT SURGICAL REPAIR WITH ORTHADAPT AUGMENTATION IN 2007. THE PT RE-RUPTURED HER ACHILLES AT THE INSERTION SITE 10-12 WEEKS POST-OP DURING THE PHYSICAL THERAPY COURSE. THE SURGEON NOTED THAT THE PT HAD A PRE-EXISTING TENDINOSIS AT THE INSERTION SITE, WHICH IS WHERE THE RE-RUPTURE OCCURRED. BASED ON THE CLINICAL ASSESSMENT AND SURGEON'S NOTE, THE PRE-EXISTING TENDINOSIS AND PT POOR NATIVE TISSUE ARE THE MOST LIKELY CAUSE OF THE ACHILLES TENDON RE-RUPTURE AND THAT THE REPORTED EVENT IS NOT GRAFT-RELATED. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) INDICATED THE DEVICE IDENTIFIED IN THIS REPORT MET ALL MFG REQUIREMENTS. THE MFR OF THE DEVICE AT THE TIME WAS PEGASUS BIOLOGICS INC. SYNOVIS ORTHOPEDIC & 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 RE-RUPTURE AT THE INSERTION SITE 10 TO 12 WEEKS POST SURGICAL REPAIR OF LEFT ACHILLES TENDON MID-SUBSTANCE RUPTURE WITH ORTHADAPT AUGMENTATION. SURGICAL REPAIR WAS PERFORMED ONE YR POST THE INITIAL SURGERY, AND SUBSEQUENTLY, THE ORTHADAPT GRAFT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHADAPT BIOIMPLANT SURGICAL MESH FTM PEGASUS BIOLOGICS, INC. OFX 2000 PCM 060816-02

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization