BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM RECONSTRUCTION PLATE - 14 HOLE

    MDR report key: 7126816 · Received December 18, 2017

    Report

    Report Number
    2027754-2017-00016
    Event Type
    Injury
    Date Received
    December 18, 2017
    Date of Event
    November 28, 2017
    Report Date
    December 18, 2017
    Manufacturer
    OSTEOMED
    Product Code
    JEY
    PMA / PMN Number
    K080694
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION HAS DEEMED THE ROOT CAUSE OF THE PLATE BREAKING COULD BE ATTRIBUTED TO UNUSUAL PATIENT CHARACTERISTICS. THERE ARE MULTIPLE PATIENT CHARACTERISTICS, OR ROOT CAUSES, FOR THE BROKEN 14-HOLE MFX 125° ANGULATED LOCKING CONTOURED RECONSTRUCTION PLATE, P/N 214-2417. SOME ARE PHYSICAL AND SOME MENTAL. IN THIS PARTICULAR CASE, THE PATIENT HAD ATTEMPTED TO COMMIT SUICIDE, WHICH PROVIDES INFORMATION CONCERNING HIS MENTAL STATE. THIS PLATE IS A PART OF THE MFX RIGID FIXATION SYSTEM. THE MFX IFU WARNS THIS SURGERY IS CONTRAINDICATED IN PATIENTS EXHIBITING DISORDERS THAT WOULD CAUSE THE PATIENT TO IGNORE THE LIMITATIONS OF RIGID FIXATION PLATE AND SCREW IMPLANTS. PHYSICALLY, THE PATIENT HAD DAMAGE TO THE MANDIBLE (CAUSED BY A GUNSHOT), AND NO UPPER OR LOWER TEETH (UNKNOWN REASONS). THE SURGEON COMMENTED ON HOW THE PLATE COULD HAVE BEEN INFLUENCED BY THESE PHYSICAL CONDITIONS MAY HAVE CAUSED IT TO BREAK. THIS PLATE/SCREW CONSTRUCT IS DESIGNED FOR TEMPORARY SUPPORT OF THE MANDIBLE UNTIL OSTEOGENESIS OCCURS, APPROXIMATELY 7-8 WEEKS OR LESS. THIS PLATE AND SCREWS BROKE 13 MONTHS AFTER RECONSTRUCTIVE SURGERY. THERE IS NO INFORMATION IF THE BONE HEALED OR IT THERE WAS AN OUTSIDE FORCE THAT BROKE THE PLATE. IN SOME CASES WHERE BOTH AN IMPLANTED PLATE AND SCREWS ARE BROKEN, THIS COULD BE DUE TO PATIENT NON-COMPLIANCE AND NON-UNION OF THE BONE. THE LOT NUMBER WAS UNKNOWN. THEREFORE, A REVIEW OF THE DHR COULD NOT BE PERFORMED. A REVIEW OF CAPAS DID NOT IDENTIFY ANY INTERNAL INVESTIGATIONS FOR THIS DEVICE. THE REVIEW OF NCRS DID NOT IDENTIFY ANY INTERNAL INVESTIGATIONS RELATED TO THE STRENGTH OF THE DEVICE. THE REVIEW OF COMPLAINTS SHOW THAT THIS IS THE SECOND COMPLAINT EVER RECEIVED FOR THIS DEVICE. THE RISK OF A PLATE BREAKING IS COVERED IN THE MFX FMEA. ALL POSSIBLE CAUSES HAVE A SEVERITY RATING OF 4, WITH A PROBABILITY RATING OF 1. PER THE RISK MANAGEMENT PROCEDURE, A RATING OF 4 INDICATES A "CRITICAL" SEVERITY LEVEL (RESULTS IN PERMANENT IMPAIRMENT REQUIRING PROFESSIONAL MEDICAL INTERVENTION). A PROBABILITY RATING OF 1 INDICATES A "LOW" (UNLIKELY TO HAPPEN, RARE, REMOTE) PROBABILITY. THIS ISSUE WILL BE MONITORED THROUGH ROUTINE TRENDING.

    Description of Event or Problem · 1

    DR. (B)(6) DID A MANDIBLE RECON ON A PATIENT WITH A SELF-INFLICTED GUNSHOT TO THE MANDIBLE. SHE USED PLATE 214-2417 TO RECONSTRUCT THE PATIENT'S SYMPHYSIS IN (B)(6) 2016 - NO BONE GRAFTING WAS DONE. THE PLATE WAS FIXATED WITH 2.4 LOCKING AND NON-LOCKING SCREWS (225-24XX AND 206-24XX). A TOTAL OF SIX (6) SCREWS WERE USED. THE PATIENT WAS IN PRISON, AND 3 WEEKS AGO CAME BACK INTO DR. (B)(6) CLINIC WITH A BROKEN PLATE. IN SURGERY, THE PLATE WAS REMOVED, ALONG WITH SCREWS THAT WERE BROKEN OFF IN THE PATIENT'S BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906209 2.4MM RECONSTRUCTION PLATE - 14 HOLE 2.4MM RECONSTRUCTION PLATE - 14 HOLE JEY OSTEOMED

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention