BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SROM NCK TRL 36MM STD +6 LAT

    MDR report key: 7103793 · Received December 11, 2017

    Report

    Report Number
    1818910-2017-51125
    Event Type
    Malfunction
    Date Received
    December 11, 2017
    Date of Event
    November 11, 2017
    Report Date
    November 11, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LXH
    UDI-DI
    10603295172895
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # PC-(B)(4). INVESTIGATION SUMMARY EXAMINATION OF THE RETURNED INSTRUMENT CONFIRMED THE COMPLAINT. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALL OF THE 10 SROM INSTRUMENTS WERE DEEMED TO BE UNUSABLE BECAUSE THE SIZE MARKINGS ARE NO LONGER VISIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884876 SROM NCK TRL 36MM STD +6 LAT TRIAL INSTRUMENT LXH DEPUY ORTHOPAEDICS INC US 10603295172895

    Patients

    Seq Age Sex Outcome Treatment
    1