BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC JR. DISTRACTOR, RIGHT 52MM

    MDR report key: 19669425 · Received July 3, 2024

    Report

    Report Number
    2027754-2024-00034
    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
    UDI-DI
    00845694004466
    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 RELATED TO THIS DEVICE OR THIS ISSUE WITHIN THE REVIEW TIMEFRAME. THE DISTRACTOR, PART-NUMBER 216-1001 WAS RETURNED FOR EVALUATION. UPON INSPECTION, IT WAS SIGNS OF USAGE/WEAR SUCH AS SCRATCHES WERE NOTED ON THE SURFACE OF THE RETURNED DISTRACTOR. VISUAL INSPECTION WAS PERFORMED BY QUALITY ASSURANCE TECHNICIAN, WHO OBSERVED THAT THE THREADS APPEARED DAMAGED, BUT IT WAS UNCLEAR WHAT COULD CAUSE THE DAMAGE. FUNCTIONAL TESTING WAS ALSO PERFORMED BY INSERTING A PIN GAUGE, INTO THE THREADS; HOWEVER, THE GAUGE WOULD NOT FULLY INSERT OR TURN INSIDE OF THE DISTRACTOR. THE REPORTED ACTIVATION WIRE THAT WAS USED DURING THE REPORTED EVENT WAS NOT RETURNED FOR EVALUATION. 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 ACTIVATION 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
    472712 LOGIC JR. DISTRACTOR, RIGHT 52MM EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR MQN OSTEOMED, LLC 216-1001 1178969 00845694004466

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Male Other