BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM MADE DEVICE LEUNG PM-TMJ & MODEL

    MDR report key: 7773775 · Received August 10, 2018

    Report

    Report Number
    0001032347-2018-00538
    Event Type
    Injury
    Date Received
    August 10, 2018
    Date of Event
    July 10, 2018
    Report Date
    January 31, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    PN/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE DESIGN VENDOR CONDUCTED AN INVESTIGATION INTO THE COMPLAINT; THEIR RESULTS ARE AS FOLLOWS: THE SURGEON PROVIDED STONE MODELS TO PRODUCE OCCLUSIONAL SPLINTS FOR THE TMJ CASE PER DENTAL MODEL SCANNING AND TMJ COMPONENT DESIGN PROCEDURES. PARTS WERE FIT CHECKED DURING TMJ-PMI FINAL MODEL INSPECTION AND APPROVED FOR SHIPMENT BY TMJ AND QA PERSONNEL. REVIEW OF DIGITAL FILES VERIFY THE FIT OF THE STONE MODELS TO THE SPLINTS MANUFACTURED. NO ROOT CAUSE COULD BE DETERMINED DURING THE INVESTIGATION OR ON A WEB MEETING WITH THE SURGEON HELD ON (B)(6) 2018. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. POTENTIAL CONTRIBUTING FACTORS COULD INCLUDE PATIENT CONDITION OF HETEROTOPIC BONE GROWTH AND A POTENTIAL CHANGE IN PATIENT ANATOMY THAT OCCURRED AFTER THE MOLD WAS TAKEN. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) NUMBER: THIS PRODUCT IS A CUSTOM MADE DEVICE THAT IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS BIOMET MICROFIXATION MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER PMA NUMBER P020016. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SPLINT DID NOT FIT. THE SURGEON IMPLANTED A CUSTOM TEMPOROMANDIBULAR JOINT (TMJ) IN THE PATIENT. IT WAS AN EXTREMELY DIFFICULT CASE THAT LASTED 13.5 HOURS, WITH THE JOINTS BEING PLACED TOWARDS THE END OF THE CASE WHEN BOTH SIDES WERE RELEASED OF HETEROTOPIC BONE. WHEN THE SURGEON ATTEMPTED TO PLACE THE SPLINT, HE FOUND THE SPLINT DID NOT FIT. SPECIFICALLY, MOST OF THE TEETH DID NOT FIT INTO THE SPLINT. THE SPLINT WAS NOT EVEN USABLE IF HE BURRED IT DOWN. THE SURGEON HAD TO ABANDONED THE SPLINT AND WIRE TEETH TO TEETH TO GET AS CLOSE AN OCCLUSION AS HE COULD SO THAT THE JOINTS WOULD FIT. IN THE END, THE JOINTS DID FIT. THE PROCEDURE WAS DELAYED BY A FEW HOURS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613777 CUSTOM MADE DEVICE LEUNG PM-TMJ & MODEL CUSTOM MADE TMJ LZD BIOMET MICROFIXATION N/A 842380A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention