BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    90 DEG LOCKING CANNULATED INFANT BLADE 35MM X 5MM X 3 HOLE

    MDR report key: 23380666 · Received October 24, 2025

    Report

    Report Number
    3006460162-2025-00060
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Date of Event
    September 26, 2025
    Report Date
    October 24, 2025
    Manufacturer
    ORTHOPEDIATRICS
    Product Code
    HRS
    UDI-DI
    00841132109717
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DR. (B)(6) FROM (B)(6) HOSPITAL REPORTED A POST-OPERATIVE ISSUE INVOLVING A TRAUMA & DEFORMITY SYSTEM, SPECIFICALLY AN LCB BLADE PLATE (PART NUMBER: 00-1200-1002, LOT NUMBER: 241069-B), WHICH HAD BEEN IN USE FOR LESS THAN SIX MONTHS. THE DEVICE WAS IMPLANTED IN AN 8-YEAR-OLD FEMALE PATIENT (INITIALS (B)(6)) ON (B)(6) 2025 AND WAS REMOVED ON (B)(6) 2025, AFTER THE PLATE BROKE. THE ISSUE WAS DISCOVERED DURING A CLINIC VISIT POST-OPERATION. THE BROKEN DEVICE WAS SCRAPPED AND NOT RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1613070 90 DEG LOCKING CANNULATED INFANT BLADE 35MM X 5MM X 3 HOLE 90 DEG LOCKING CANNULATED INFANT BLADE 35MM X 5MM X 3 HOLE HRS ORTHOPEDIATRICS 00-1200-1002 241069-B 00841132109717

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Female Required Intervention| O