BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT 0 DEG INSERT TRL 32MM

    MDR report key: 275133 · Received April 20, 2000

    Report

    Report Number
    2243265-2000-00022
    Event Type
    Malfunction
    Date Received
    April 20, 2000
    Report Date
    April 20, 2000
    Manufacturer
    HOWMEDICA INC.
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A SURGERY, TRIAL HEAD WAS STUCK IN TRIAL INSERT CAT# 2200-32-E. IT WAS VERY DIFFICULT TO REMOVE THE TRIALS FROM THE PT. 40 MINS SURGERY DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT 0 DEG INSERT TRL 32MM INSTRUMENT LXH HOWMEDICA INC. NA 1SNMH

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other