BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHADAPT BIOIMPLANT

    MDR report key: 1895496 · Received November 5, 2010

    Report

    Report Number
    3005147058-2010-00004
    Event Type
    Injury
    Date Received
    November 5, 2010
    Report Date
    November 4, 2010
    Manufacturer
    PEGASUS BIOLOGICS, INC.
    Product Code
    FTM
    PMA / PMN Number
    K071065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INITIAL INVESTIGATION OF PEGASUS BIOLOGICS' DISTRIBUTION RECORDS, THIS CASE MAY HAVE BEEN ASSOCIATED WITH REPORTED USE OF AN ORTHADAPT BIOIMPLANT IN A LEFT 1ST METATARSOPHALANGEAL JOINT (MPJ) ARTHROPLASTY. THE PT, HOWEVER, REPORTED IMPLANTS IN BOTH GREAT TOES. THE ORTHADAPT IS NOT INTENDED FOR USE IN MPJ ARTHROPLASTY. SYNOVIS ORTHOPEDIC AND WOUNDCARE HAS CONTACTED THE PT'S PHYSICIAN TO OBTAIN FURTHER INFO CONCERNING THIS EVENT, BUT HAS NOT RECEIVED A RESPONSE AS OF THIS REPORT. BASED ON THE INFO RECEIVED TO DATE, NEITHER THE POSITIVE IDENTITY OF THE DEVICE ASSOCIATED WITH THIS EVENT NOR THE CAUSE OF THE EVENT COULD BE DETERMINED. ASSUMING THE PRODUCT WAS AN ORTHADAPT BIOIMPLANT, IT APPEARS THAT THE PRODUCT WAS USED CONTRARY TO ITS INTENDED USE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBERS WHICH MAY HAVE BEEN ASSOCIATED WITH THIS EVENT INDICATED THAT THE LOT MET ALL MFG REQUIREMENTS AT THE TIME OF RELEASE. THE MFR OF THE DEVICE WAS PEGASUS BIOLOGICS, INC, SYNOVIS ORTHOPEDIC AND WOUNDCARE, INC. IS THE REPORTING COMPANY FOR THIS EVENT.

    Description of Event or Problem · 1

    PT WROTE A LETTER TO THE COMPANY REPORTING PAIN IN HER FEET AND CYST-LIKE GROWTHS FOLLOWING AN "ARTIFICIAL TISSUE IMPLANT IN BOTH GREAT TOES." THE PT REPORTED THAT SHE HAD UNDERGONE SEVERAL SURGERIES TO HAVE IT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHADAPT BIOIMPLANT SURGICAL MESH FTM PEGASUS BIOLOGICS, INC. OFX 2500 2500A1012A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention