BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHADAPT BIOIMPLANT

    MDR report key: 1559605 · Received December 11, 2009

    Report

    Report Number
    3005147058-2009-00123
    Event Type
    Injury
    Date Received
    December 11, 2009
    Date of Event
    July 1, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE EXCISION OF THE SYNOSTOSIS, AN ORTHADAPT (9X10CM) WAS WRAPPED AROUND THE FIBULA BETWEEN THE FIBULA AND TIBIA TO PREVENT A FUTURE MALUNION. THE SURGEON USED A 2.5 MM STATAK SUTURE ANCHOR AND 2-0 VICRYL SUTURE TO SEW THE BIOIMPLANT IN PLACE TIGHTLY TO THE BONE. AT 4 WEEKS POST OP, THE PATIENT HAD SIGNIFICANTLY IMPROVED RANGE OF MOTION AND WAS PAIN-FREE. AT 6 WEEKS POST OP, THE PATIENT WAS SEEN AGAIN AND REPORTED NO SYMPTOMS. ONE WEEK LATER, THE PATIENT CAME IN WITH EXCESSIVE SWELLING IN HER RIGHT ANKLE; THE SURGEON STATED, THE PATIENT HAD BECOME NON-COMPLIANT BECAUSE SHE WAS FEELING BETTER AND HAD FALLEN WHILE OUT ONE EVENING. DURING THE EXPLANT, THE SURGEON NOTED THE GRAFT WAS ATTACHED LATERALLY, BUT IT SEEMED AS THOUGH THE GRAFT HAD RIPPED MEDIALLY (BETWEEN THE TIBIA & FIBULA). NO OTHER INFORMATION WAS PROVIDED. THIS IS AN OFF LABEL PROCEDURE. ALSO, THE IFU INDICATES ONLY NON-ABSORBABLE SUTURE TO FIXATE THE BIOIMPLANT. BASED ON THE PROVIDED INFORMATION, THE OFF LABEL USE AND TRAUMA ARE THE LIKELY CAUSE OF THE EVENT. THE MANUFACTURER OF THE DEVICE AT THE TIME WAS PEGASUS BIOLOGICS, INC.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED SWELLING IN THE RIGHT ANKLE AFTER FALLING APPROXIMATELY 7 WEEKS POST EXCISION OF SYNOSTOSIS IN THE ANKLE (AT THE DISTAL PART OF THE FIBULA AND TIBIA) AND USE OF ORTHADAPT BIOIMPLANT AS A WRAP AROUND THE FIBULA AND BETWEEN THE FIBULA AND TIBIA. ONE WEEK LATER, YELLOWISH-CLEAR FLUID WAS ASPIRATED AND APPROXIMATELY 5 WEEKS LATER, THE BIOIMPLANT WAS EXPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization