BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICELOCK 621 RATCHED

    MDR report key: 16477447 · Received March 3, 2023

    Report

    Report Number
    3003764610-2023-00006
    Event Type
    Malfunction
    Date Received
    March 3, 2023
    Date of Event
    September 22, 2022
    Report Date
    March 3, 2023
    Manufacturer
    OSSUR HF
    Product Code
    ISH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LOCK FAILED TO PROVIDE SECURE SUSPENSION RESULTING IN DEVICE COMING OFF WHILE USER WAS CLIMBING STAIRS. PRODUCT HAD BEEN IN USE FOR 4 MONTHS. THE LOCKING PLATE AND LOCKING PINS WERE FOUND WORN. PRODUCT WEAR IS A KNOWN DISADVANTAGE WITH RATCHET LOCK WHERE UNHARDENED GUIDE PLATE MAY HAVE BEEN MORE SUSCEPTIBLE TO A BINDING EFFECT BETWEEN SIMILAR STAINLESS-STEEL MATERIAL AND SUBSEQUENT FASTER WEAR DOWN. CAPA IS IN PROGRESS AND PRODUCT IMPROVEMENTS HAVE BEEN IMPLEMENTED.

    Description of Event or Problem · 0

    THE USER REPORTED THE DEVICE COMING OFF WHILE CLIMBING STAIRS. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1934270 ICELOCK 621 RATCHED PROSTHETIC LOCK ISH OSSUR HF L-621000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown