BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ARTELON FLEXBAND

    MDR report key: 20981686 · Received December 19, 2024

    Report

    Report Number
    3010673515-2024-00063
    Event Type
    Injury
    Date Received
    December 19, 2024
    Date of Event
    February 1, 2024
    Report Date
    December 19, 2024
    Manufacturer
    ARTELON
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE IS PART OF A REMEDIATION PERFORMED BY STRYKER FOLLOWING THE ACQUISITION OF ARTELON COMPANY. THE INVESTIGATION OF THIS CASE HAS BEEN COMPLETED, AND NO ADDITIONAL INFORMATION IS AVAILABLE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE CASE WILL BE REOPENED, AND A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE OF A STUDY FROM THE FOOT & ANKLE SPECIALIST JOURNAL. THE TITLE OF THIS STUDY IS ¿EVALUATION OF A BIODEGRADABLE SYNTHETIC MATRIX FOR LATERAL ANKLE LIGAMENT SURGICAL REPAIR AUGMENTATION: AN OPEN LABEL CONTROLLED MULTICENTER RETROSPECTIVE REVIEW¿ AND IS ASSOCIATED WITH THE FLEXBAND/FLEXPATCH SYSTEMS. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ADVERSE EVENTS WERE REPORTED. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE CATALOGS FROM THE REPORT, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 35 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES THAT ONE PATIENT UNDERWENT PARTIAL METATARSAL EXCISION, FHL TENOLYSIS AND SESAMOID EXCISION DUE TO A GREAT TOE ULCERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2365315 UNKNOWN ARTELON FLEXBAND MESH, SURGICAL, POLYMERIC FTL ARTELON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention