BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4WEB MEDICAL

    MDR report key: 13511193 · Received February 11, 2022

    Report

    Report Number
    3009189869-2022-00004
    Event Type
    Injury
    Date Received
    February 11, 2022
    Date of Event
    May 16, 2018
    Report Date
    February 10, 2022
    Manufacturer
    4WEB, INC.
    Product Code
    PLF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT OF THIS FILING WAS UNIQUELY DESIGNED FOR THIS PATIENT'S SPECIFIC PATHOLOGY BY THE PRESCRIBING PHYSICIAN. THERE WAS NO NON-COMPLIANCE NOTED BY THE SURGEON WITH REGARD TO THE PATIENT FOLLOWING POST-OPERATIVE INSTRUCTIONS. THE PATIENT HAD A HISTORY OF SEVERAL RIGHT ANKLE PROCEDURES PERFORMED PRIOR TO THE ORIGINAL SURGERY WITH 4WEB'S CUSTOM-MADE DEVICE. THE PATIENT ALSO HAD PRE-EXISITING CONDITIONS INCLUDING HIGH BLOOD PRESSURE, DIABETES MELLITUS, AND OSTEOARTHRITIS. THIS INCIDENT WAS IDENTIFIED BY THE MANUFACTURER DURING A RETROSPECTIVE STUDY OF 4WEB CUSTOM-MADE DEVICES IN (B)(6) 2022. NO OTHER COMPLICATIONS HAVE BEEN REPORTED TO THE MANUFACTURER FOLLOWING THE REVISION SURGERY WITH THE NEW CUSTOM-MADE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO THE MANUFACTURER ON 13 JANUARY 2022 THAT A RIGHT ANKLE CUSTOM-MADE DEVICE REVISION WAS PERFORMED ON (B)(6) 2018. THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2013 USING A THIRD-PARTY LATERAL PLATE FIXATION. ON (B)(6) 2015, THE SURGEON IDENTIFIED MULTIPLE SCREW FRACTURES. THE PLATE AND SCREW CONSTRUCTS WERE LATER REMOVED IN (B)(6) 2015, FOLLOWING WHICH THE PATIENT WAS NOTED TO BE DOING WELL. ON (B)(6) 2017, A TOTAL KNEE REPLACEMENT WAS IMPLANTED. THE SURGEON NOTED SUBSIDENCE OF THE RIGHT ANKLE CUSTOM-MADE IMPLANT APPROXIMATELY SIX MONTHS LATER, ON (B)(6) 2017. DURING THE REVISION SURGERY PERFORMED ON (B)(6) 2018, THE ORIGINAL CUSTOM-MADE DEVICE WAS EXPLANTED AND REPLACED BY ANOTHER 4WEB CUSTOM-MADE DEVICE UTILIZING A THIRD-PARTY INTRAMEDULLARY NAIL AS SUPPLEMENTAL FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1081500 4WEB MEDICAL PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT PLF 4WEB, INC. PSI-ANK-XX 36452

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention