BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHADAPT BIOIMPLANT

    MDR report key: 2003719 · Received February 23, 2011

    Report

    Report Number
    3005147058-2011-00001
    Event Type
    Injury
    Date Received
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    PEGASUS BIOLOGICS, INC.
    Product Code
    FTM
    PMA / PMN Number
    K071065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A ROUTINE VISIT BY DISTRIBUTOR, PHYSICIAN MENTIONED THAT HE HAD USED THE ORTHADAPT BIOIMPLANT AS PART OF A TENDON REPAIR PROCEDURE (LATERAL ANKLE INSTABILITY). THE REVISION PROCEDURE, INCLUDING REMOVAL OF REMAINING ORTHADAPT MATERIAL, OCCURRED APPROX ONE YEAR PRIOR TO THE PHYSICIAN'S REPORT. DURING A FOLLOW-UP CONVERSATION, THE PHYSICIAN INDICATED THAT THE ORTHADAPT HAD BEEN IMPLANTED APPROX TWO YEARS AGO. THE MODEL NUMBER AND LOT NUMBER WERE NOT REPORTED AND COULD NOT BE DETERMINED AS OF THIS REPORT. BASED ON THE AVAILABLE INFO, NO CONCLUSIONS CAN BE DRAWN AS TO THE CAUSE OF THE THIS EVENT. THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER OF THE DEVICE WERE PEGASUS BIOLOGICS, INC., SYNOVIS ORTHOPEDIC AND WOUNDCARE, INC. ARE THE REPORTING COMPANY FOR THE EVENT. THE IMPLANT OCCURRED PRIOR TO THE SYNOVIS ACQUISITION OF PEGASUS BIOLOGICS.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED THAT FOLLOWING TENDON REPAIR FOR LATERAL ANKLE INSTABILITY WITH ORTHADAPT BIOIMPLANT AUGMENTATION, THE PT DEVELOPED A FOREIGN BODY RESPONSE. THE REMAINING ORTHADAPT MATERIAL WAS SUBSEQUENTLY 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 UNK Required Intervention NOT AVAILABLE