BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M3M4

    MDR report key: 5022816 · Received August 21, 2015

    Report

    Report Number
    2027754-2015-00011
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Date of Event
    June 30, 2015
    Report Date
    January 2, 2018
    Manufacturer
    OSTEOMED
    Product Code
    DZL
    PMA / PMN Number
    K911936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT PERTAINS TO A MINI 10 HOLE STRAIGHT PLATE, RIGID (PART NUMBER 210-0232) THAT WAS REPORTED BROKEN BY THE USER SEVERAL MONTHS AFTER IMPLANTATION. THE PATIENT WAS A FEMALE, (B)(6) YEARS OLD, WEIGHING (B)(6). X-RAYS WERE PROVIDED BY THE PHYSICIAN OF THE FRACTURED PLATE. THE PROCEDURE APPEARS HAVE BEEN PERFORMED PER THE SURGICAL TECHNIQUE INSTRUCTIONS. THE PLATE ON THE PATIENT'S LEFT MANDIBLE FRACTURED AT THE THINNEST LOCATION BETWEEN THE EMPTY HOLE AND THE FIRST SCREW CLOSEST TO THE OSTEOTOMY ON THE PORTION OF THE PLATE AFFIXED TO THE CONDYLE. THIS TYPE OF FRACTURE IS CONSISTENT WITH PLATE FAILURE WHERE REPEATED STRESSES WEAKEN AND ULTIMATELY FRACTURE THE PLATE. THE THICKNESS OF THE 210-0232 PLATE IS .031" (0.8MM). TYPICALLY PLATES WITH THIS THICKNESS ARE USED IN CRANIOFACIAL PROCEDURES IN THICKER BONE OF THE MAXILLA AND LOWER MIDFACE, AND USE NON-LOCKING SCREWS WITH LARGE COUNTERSINKS TO GIVE THE MAXIMUM ANGULARITY WHEN FIXATING THE PLATE ABOUT VARIOUS CURVES OF THE CRANIOFACIAL BONY ANATOMY. HOWEVER, TYPICAL PLATES USED FOR MANDIBULAR FIXATION IN OTHER OSTEOMED SYSTEMS SUCH AS THE CFX RIGID FIXATION SYSTEM AND THE ANGLED LOCKING RECONSTRUCTION PLATES OF THE ICON MODULAR LOCKING FIXATION SYSTEM USE PLATES THAT ARE AT LEAST .079" (1MM) THICK AND REQUIRE THE USE OF ANGLED LOCKING SCREWS, WHICH ENSURE THE PLATE/SCREW INTERFACE DOES NOT ALLOW MOVEMENT IN AREAS OF HIGH FUNCTIONAL STRESS. ACCORDING TO IFU 030-1552, WARNING #2 NOTES THAT "USE OF AN UNDERSIZED PLATE OR SCREW IN AREAS OF HIGH FUNCTIONAL STRESSES MAY LEAD TO IMPLANT FRACTURE AND FAILURE." GIVEN THE PLACEMENT OF THE PLATE, THE PRESENCE OF HIGH FUNCTIONAL STRESSES IN THE MANDIBLE, AND THE PLATE THICKNESS BEING THINNER THAN IS TYPICALLY USED, IT IS LIKELY THAT THE SURGEON USED AN UNDERSIZED PLATE FOR THE APPLICATION. QA NOTE: DURING AN AUDIT OF MDR SUBMISSIONS, WE IDENTIFIED THAT THERE WAS AN ERROR ON THE FOLLOW-UP REPORT THAT PREVENTED UPLOAD TO MAUDE. THEREFORE, THIS REPORT IS BEING RE-SUBMITTED. DATE OF ORIGINAL UPDATE REPORT: 08/21/2015.

    Description of Event or Problem · 1

    ON (B)(4) 2015 OSTEOMED WAS NOTIFIED OF AN INCIDENT CONCERNING THE 10 HOLE STRAIGHT RIGID PLATE. THE PLATE BROKE SOME TIME AFTER THE SURGICAL OPERATION. THE HOSPITAL HAS REPORTED THE INCIDENT TO THE (B)(6).

    Description of Event or Problem · 1

    ON 07/28/2015 OSTEOMED WAS NOTIFIED OF AN INCIDENT CONCERNING THE 10 HOLE STRAIGHT RIGID PLATE. THE PLATE BROKE SOME TIME AFTER THE SURGICAL OPERATION. THE HOSPITAL HAS REPORTED THE INCIDENT TO THE NATIONAL SECURITY AGENCY FOR MEDICINES AND HEALTH PRODUCTS (ANSM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555391 M3M4 10 HOLE STRAIGHT RIGID PLATE DZL OSTEOMED UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention