BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRANIOFACIAL RIGID FIXATION SYSTEM

    MDR report key: 3472267 · Received November 7, 2013

    Report

    Report Number
    2027754-2013-00009
    Event Type
    Injury
    Date Received
    November 7, 2013
    Date of Event
    September 1, 2013
    Report Date
    November 5, 2013
    Manufacturer
    OSTEOMED
    Product Code
    MQN
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE X-RAYS AND BROKEN PIECES OF PLATES SENT BACK TO US, IT WAS DETERMINED THAT NOT ALL OF THE FOUR PLATES HAD BROKEN AS INITIALLY REPORTED. TWO OF THE FOUR PLATES IMPLANTED HAD BROKEN. THE OTHER TWO PLATES WERE PERFORMED (BENT) BUT NOT BROKEN. IT IS BELIEVED THAT THE PLATES WHICH WERE BROKEN WERE PN 213-0001 (13 MM LEFT L PLATES) AND 213-003 (15 MM RIGHT L PLATE) WHICH WERE ON THE RIGHT SIDE OF THE FACE. THE ROOT CAUSE OF THE BREAKAGE COULD NOT BE DETERMINED BECAUSE ADDITIONAL INFORMATION SUCH AS LOT NUMBER, WHEN THE DOCTOR DISCOVERED THE PLATES WERE BROKEN, CIRCUMSTANCES SURROUNDING THE BREAKAGE, DID THE PATIENT FOLLOW POST OPERATIVE PROCEDURES, DID THE PATIENT EXPERIENCE ANY SORT OF TRAUMA TO THE FACE, ETC. AS REQUESTED WAS NOT RECEIVED. IN ADDITION, THE RETURNED DEVICES COULD NOT BE TESTED TO SEE IF THEY WERE IN SPECIFICATION BECAUSE THEY WERE IN PIECES OR DEFORMED. THE TERRITORY MANAGER BELIEVES THAT THE PLATES WERE MANIPULATED AND PUT BACK INTO THE PROPER BEND WHICH WOULD CAUSE THE PLATES TO WEAKEN. THE IFU STATES THAT MULTIPLE BENDING OF THE PLATES MAY WEAKEN THE PLATE AND COULD RESULT IN IMPLANT FRACTURE AND FAILURE. NO OTHER BREAKAGE COMPLAINTS ARE NOTED BY OSTEOMED FOR PART NUMBERS 213-0001, 213-0002, 213-0003, AND 213-0004 PLATES. COMPLAINTS WILL CONTINUE TO BE MONITORED FOR TRENDS. IF NECESSARY, PREVENTIVE ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 1

    THE 1.6 MM PLATES USED FOR A LEFORT I ORTHOGNATHIC CORRECTIVE JAW SURGERY BROKE. THE FOLLOWING 1.6 MM PLATES WERE IMPLANTED IN A PATIENT ON (B)(6) 2013 AND EXPLANTED ON (B)(6)2013. IT IS NOT KNOWN WHEN THE PLATES WERE DISCOVERED TO BE BROKEN BY THE PATIENT OR THE DOCTOR. THE DOCTOR ADVISED THE COMPANY REPRESENTATIVE OF THE BREAKAGE AND EXPLANT ON (B)(6) 2013. THE PLATES WERE REPLACED AFTER THE EXPLANT ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575819 CRANIOFACIAL RIGID FIXATION SYSTEM 1.6 MM L PLATES MQN OSTEOMED NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention