BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFIX RC

    MDR report key: 237377 · Received August 24, 1999

    Report

    Report Number
    1223420-1999-00002
    Event Type
    Malfunction
    Date Received
    August 24, 1999
    Report Date
    August 24, 1999
    Manufacturer
    LI MEDICAL TECHNOLOGIES, INC.
    Product Code
    JDR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ANCHOR PULLED POST-OPERATIVELY, SURGICAL INTERVENTION REQUIRED TO REMOVE ANCHOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFIX RC Implant SUTURE ANCHOR JDR LI MEDICAL TECHNOLOGIES, INC. UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention