BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16850859 · Received May 1, 2023

    Report

    Report Number
    3006460162-2023-00016
    Event Type
    Malfunction
    Date Received
    May 1, 2023
    Report Date
    May 1, 2023
    Manufacturer
    ORTHOPEDIATRICS, CORP
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    SURGEON DID A LEFT SIDE LCB INFANT ON A 4Y 8MO PATIENT WITH ABOUT 15.8KG. THE SURGERY WAS SMOOTH WITH NO COMPLICATIONS. THE POSTOP UNTIL DAY 15 WAS NORMAL. THE DAY AFTER THEY ARRIVED IN THEIR HOMETOWN THE PATIENT STARTED WITH PAIN ON THE LEFT SITE, AND THEY TRAVELED BACK TO SAO PAULO WHERE DR. MORAIS FOUND THAT THE PLATE WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124047 90 DEG LOCKING CANNULATED INFANT BLADE 35MM X 5MM X 3 HOLE LOCKING CANNULATED INFANT BLADE HRS ORTHOPEDIATRICS, CORP 00-1200-1002 221453-B

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Unknown Hospitalization