BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC

    MDR report key: 3161580 · Received May 7, 2013

    Report

    Report Number
    2027754-2013-00004
    Event Type
    Injury
    Date Received
    May 7, 2013
    Date of Event
    April 5, 2013
    Report Date
    June 6, 2013
    Manufacturer
    OSTEOMED
    Product Code
    MQN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE PAST SEVEN YEARS, THERE HAVE BEEN NO OTHER COMPLAINTS RELATED TO BREAKAGE OF THE LOGIC ACTIVATION WIRE 52 MM. IN ADDITION, THERE ARE NO OTHER COMPLAINTS OF ONE DOCTOR BREAKING THREE CONSECUTIVE ACTIVATION WIRES. DR (B)(6) HAS PERFORMED ONLY ONE OTHER LOGIC CASE WHICH WAS APPROXIMATELY A YEAR AGO. ACCORDING TO INFORMATION RECEIVED, THE BUSINESS MANAGER WAS ABLE TO OBSERVE THE OPERATIONS FROM OUTSIDE THE STERILE ZONE WHICH WAS APPROXIMATELY 1.5 METERS FROM THE PATIENT AND SURGEON. ACCORDING TO THE BUSINESS MANAGER, DR (B)(6) DID NOT USE SCREWS TO FIXATE THE INFERIOR ARM OF THE STATIONARY BASE PLATE DESPITE THE BUSINESS MANAGER HAVING GONE THROUGH THE SURGICAL TECHNICAL GUIDE WITH HIM. THE SURGICAL TECHNICAL GUIDE AND IFU STATE THAT THERE ARE TWO AREAS OF THE DISTRACTOR THAT MUST BE FIXATED TO THE MANDIBLE: THE STATIONARY BASE PLATE AND THE MOVING PLATE. NOT PLACING SCREWS INTO THE INFERIOR ARM ON THE STATIONARY BASE PLATE COULD CAUSE THE DISTRACTOR TO TWIST AND THE WIRES TO BEND. THIS SPECIFIC IFU AND SURGICAL TECHNIQUE GUIDE INSTRUCTION WERE NOT FOLLOWED BY THE DOCTOR. THE IFU ALSO STATES THAT FAILURE TO FOLLOW IMPLANTATION INSTRUCTIONS MAY CAUSE PATIENT HARM OR DEVICE DAMAGE. THE TERRITORY MANAGER WAS GIVEN A LIST OF COMMON MISTAKES SEEN IN THE LABS WITH THE SURGEON AS WELL AS SUGGESTION TO SURGEONS LEARNING TO USE THE LOGIC MANDIBULAR DISTRACTION SYSTEM WHICH SHOULD BE SHARED WITH THE DOCTOR. NOTE: THE BROKEN ACTIVATION WIRES WERE EXAMINED BY THE ENGINEER AND NO SIGNIFICANT BREAKAGE ASSESSMENT COULD BE DETERMINED BASED ON A VISUAL EXAMINATION.

    Description of Event or Problem · 1

    A TOTAL OF FOUR ACTIVATION WIRES BROKE. ONE WIRE BROKE WHEN ATTEMPTING TO BE IMPLANTED. IT WAS DISCARDED AT THE HOSPITAL. (B)(6) 2013, THE DOCTOR IMPLANTED TWO 52 MM ACTIVATION WIRES. LATER ON THE DOCTOR NOTICED THAT ONE OF THE TWO WIRES HAD BROKEN. ON (B)(6) 2013, THE BROKEN WIRE WAS EXPLANTED AND THE DOCTOR ATTEMPTED TO IMPLANT ANOTHER 52 MM WIRE WHICH BROKE. HE THEN ATTEMPTED TO IMPLANT ANOTHER 52 MM WIRE WHICH ALSO BROKE. A 62 MM ACTIVATION WIRE WAS SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197936 LOGIC ACTIVATION WIRE MQN OSTEOMED 1056505

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention