BEUDAMED
    FDA Adverse Event Other Summary report: N

    L SHAPED LSMI THREADLOCK DISTRACTOR, RIGHT

    MDR report key: 924816 · Received October 5, 2007

    Report

    Report Number
    1032347-2007-00027
    Event Type
    Other
    Date Received
    October 5, 2007
    Date of Event
    September 20, 2007
    Report Date
    September 20, 2007
    Manufacturer
    BIOMET MICROFIXATION, INC.
    Product Code
    JEY
    PMA / PMN Number
    K030425
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. IFU INDICATES THE DEVICE CAN BREAK, BEND OR BE DAMAGED AS A RESULT OF STRESS, ACTIVITY, AND LOAD BEARING. CURRENT INFO IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADD'L INFO IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. ADVISED USER FACILITY OF MEDWATCH FILING. 1032347-2007-00026 & 00027. REPORT FROM VISUAL REVIEW OF EXPLANTED PRODUCT. PHYSICIAN CONFIRMED (ALONG WITH POST OP PICTURES IN OR) THE EXTENSIONS WERE NOT HELD AGAINST THE PT'S HEAD AND ALLOWED TO DANGLE FREELY. ENGINEER BELIEVES IT IS LIKELY THE EXTENSIONS CAUGHT ON SOMETHING FORCING THEM LATERALLY AWAY FROM THE MANDIBLE (OR INFERIOR /SUPERIOR) TO CAUSE THE HOUSING TO BREAK. FURTHERMORE, ENGINEER NOTED THE EXTENSION OF THE PT'S RIGHT SIDE HAD BROKEN NEAR THE WELD CONNECTION BETWEEN THE THREADED SECTION AND FLEXIBLE EXTENSION.

    Description of Event or Problem · 1

    MANDIBULAR DISTRACTION. DEVICE IMPLANTED IN 2007. THE NEXT MONTH, DOCTOR NOTICED ACTIVATION OF THE DRIVE SCREW WAS NOT ADVANCING BONE SEGMENTS. REVISION SURGERY FIVE DAYS LATER, DISCOVERED THE HOUSING OF THE LACTOSORB FOOT PLATE HAD BROKEN ALONG THE LENGTH OF THE INTERNAL THREADS OF THE PROXIMAL PLATE, WHERE THE HOUSING BLENDS INTO THE FLAT PORTION OF THE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L SHAPED LSMI THREADLOCK DISTRACTOR, RIGHT LACTOSORB DISTRACTION JEY BIOMET MICROFIXATION, INC. 871450

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Required Intervention FIXATE PLATES| (SEE 1032347-2007-0027). SCREWS WERE USED TO| LEFT AND RIGHT DISTRACTION PLATES WERE USED