BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4WEB OSTEOTOMY TRUSS SYSTEM

    MDR report key: 10805934 · Received November 7, 2020

    Report

    Report Number
    3009189869-2020-00014
    Event Type
    Injury
    Date Received
    November 7, 2020
    Date of Event
    November 3, 2020
    Report Date
    December 23, 2020
    Manufacturer
    4WEB, INC.
    Product Code
    HRS
    PMA / PMN Number
    K172294
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINANT REPORTED THAT A REVISION SURGERY WAS REQUIRED DUE TO NON-UNION OF AN OSTEOTOMY WEDGE. THE IMPLANT WAS EXPLANTED ABOUT TWO AND A HALF YEARS AFTER THE ORIGINAL SURGERY. THE IMPLANT WAS REPLACED BY A BONE WEDGE WITH PLATE. THE IMPLANT WAS NOT RETURNED FOR INVESTIGATION NOR WERE ANY RADIOGRAPHS PROVIDED. THE PRODUCTION RECORDS WERE REVIEWED FOR THE PRODUCT INVOLVED. NO MANUFACTURING DEFICIENCES WERE IDENTIFED THAT COULD HAVE CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED TO THE MANUFACTURER. NO RADIOGRAPHS WERE PROVIDED. THERE WAS NO INFORMATION AVAILABLE ON WHETHER THE PATIENT WAS COMPLIANT WITH POST-OPERATIVE INSTRUCTIONS. INFORMATION RECEIVED INDICATED THAT SUPPLEMENTAL FIXATION WAS NOT USED DURING THE INITIAL SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO 4WEB THAT A REVISION SURGERY WAS REQUIRED TO BE PERFORMED ON A PATIENT WHERE NON-UNION WAS OBSERVED. THE INITIAL SURGERY WAS PERFORMED WITH A 4WEB OSTEOTOMY WEDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1270970 4WEB OSTEOTOMY TRUSS SYSTEM OSTEOTOMY WEDGE HRS 4WEB, INC. EOTS-MD2006

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention