BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT

    MDR report key: 10570600 · Received September 22, 2020

    Report

    Report Number
    3009189869-2020-00012
    Event Type
    Injury
    Date Received
    September 22, 2020
    Date of Event
    August 20, 2020
    Report Date
    September 22, 2020
    Manufacturer
    4WEB, INC.
    Product Code
    PLF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT OF THIS FILING WAS UNIQUELY DESIGNED FOR THIS PATIENT'S SPECIFIC PATHOLOGY BY THE PRESCRIBING PHYSICIAN. SURGEON INDICATED THAT HE OBSERVED AN INFECTION AND THAT THE CAGE WAS SUBSEQUENTLY EXPLANTED. REVIEW OF PRODUCTION RECORDS DID NOT INDICATE ANY ISSUES RELATED TO MANUFACTURING THAT MAY HAVE CONTRIBUTED TO THE EVENT. NO PRODUCT WAS RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    DURING POST-OPERATIVE CHECK-UPS BY THE SURGEON, HE OBSERVED AN INFECTION. THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2020. THE CUSTOM CAGE WAS EXPLANTED. NO FURTHER COMPLICATIONS WERE REPORTED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032908 PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT PLF 4WEB, INC. 101519.06D 61121191

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention