BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4WEB OSTEOTOMY TRUSS SYSTEM

    MDR report key: 8672256 · Received June 5, 2019

    Report

    Report Number
    3009189869-2019-00010
    Event Type
    Injury
    Date Received
    June 5, 2019
    Report Date
    September 4, 2019
    Manufacturer
    4WEB, INC.
    Product Code
    HRS
    PMA / PMN Number
    K130185
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    4WEB HAS NOT RECEIVED IMPLANTS OR FLUOROSCOPIC IMAGES FOR EVALUATION OF STATEMENTS MADE IN THE MEDWATCH REPORT (MW5086286). THE PATIENT INDICATED THEY HAD A REVISION SURGERY TO REMOVE A NON-4WEB STAPLE; THIS MAY OR MAY NOT HAVE CONTRIBUTED TO THE EXPLANT OF THE 4WEB WEDGE. ADDITIONALLY, PATIENT INDICATED THAT A DISTAL PORTION OF THE 4WEB WEDGE HAD BROKEN, HOWEVER, IT IS UNCLEAR IF THIS WAS BROKEN DURING REMOVAL OR PRIOR TO THE REVISION SURGERY.

    Description of Event or Problem · 1

    A MEDWATCH REPORT (MW5086286) WAS RECEIVED FROM THE FDA INDICATING THAT THE PATIENT HAD SURGERY ON (B)(6) 2017 TO REPAIR A LEFT POSTERIOR TIBIAL TENDON INJURY. THE PATIENT EXPERIENCED PAIN POST-OPERATIVELY. IN MID-2018, THE PATIENT HAD SURGERY TO REMOVE A NON-4WEB STAPLE. THE PATIENT CONTINUED TO HAVE PAIN, AND IN 2019 THE 4WEB WEDGE LOCATED IN THE PATIENT'S MIDFOOT WAS EXPLANTED AND REPLACED WITH NON-4WEB FIXATION HARDWARE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED BY THE FDA UNDER MEDWATCH REPORT NUMBER (MW5086286) AND 4WEB, INC.'S REGULAR REVIEW OF THE MEDWATCH DATABASE PROVIDED THE FOLLOWING INFORMATION FOR REVIEW AND REPORTING. THE PREVIOUS REPORT SUBMITTED INDICATED THAT THE DISTAL PORTION OF THE 4WEB WEDGE DEVICE WAS BROKEN. HOWEVER, THE ADDITIONAL INFORMATION RECEIVED FROM THE REPORTER STATES THAT THE DEVICE WAS INTACT. IT WAS ALSO STATED THAT THE "METATARSAL BONE WAS BROKEN AND HAD NOT FUSED WITH THE WEDGE DEVICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463759 4WEB OSTEOTOMY TRUSS SYSTEM OSTEOTOMY WEDGE HRS 4WEB, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention