BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVATION WIRE, 72MM

    MDR report key: 19669426 · Received July 3, 2024

    Report

    Report Number
    2027754-2024-00035
    Event Type
    Injury
    Date Received
    July 3, 2024
    Date of Event
    June 3, 2024
    Report Date
    July 3, 2024
    Manufacturer
    OSTEOMED, LLC
    Product Code
    MQN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED, AND NO ANOMALIES WERE NOTED. A REVIEW OF THE COMPLAINT DATABASE REVEALED NO OTHER COMPLAINTS FOR THIS DEVICE OR THIS ISSUE WITHIN THE REVIEW TIMEFRAME. THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IN THE PATIENT'S LEFT DISTRACTOR IN ORDER TO CONTINUE THE PATIENT'S DISTRACTION PROTOCOL. BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A MANDIBULAR DISTRACTION SURGERY ON THE RIGHT MANDIBLE OF A PEDIATRIC PATIENT, THE RIGHT DISTRACTOR WAS SECURED WITH SCREWS. THE ACTIVATION WIRE WAS INSERTED TO ADJUST THE DISTRACTOR, BUT THE WIRE WOULD NOT TURN. THE RIGHT DISTRACTOR WAS REMOVED AND WAS TESTED BY THE SURGEON ONCE REMOVED BUT WOULD NOT WORK. THE SAME ACTIVATION WIRE WAS USED IN THE LEFT DISTRACTOR AND APPEARED TO "JAM" DURING THE SECOND TURN; HOWEVER, THEY WERE ABLE TO GET THE ACTIVATION WIRE TO WORK IN THE LEFT DISTRACTOR TO COMPLETE THE LEFT SIDED DISTRACTION. THE REPORTED ACTIVIATION WIRE WAS LEFT IN THE LEFT DISTRACTOR IN ORDER TO CONTINUE TO COMPLETE THE COURSE OF THE PATIENT'S DISTRACTION PROTOCOL. ANOTHER DISTRACTOR WAS USED ON THE PATIENT'S RIGHT SIDE TO COMPLETE THE SURGERY. THIS ISSUE PROLONGED THE SURGERY BY THREE (3) HOURS. NO OTHER ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472713 ACTIVATION WIRE, 72MM EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR MQN OSTEOMED, LLC 216-0603 1169259

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Male Other