BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIMAX ARCH BAR

    MDR report key: 7110173 · Received December 12, 2017

    Report

    Report Number
    0001032347-2017-00878
    Event Type
    Injury
    Date Received
    December 12, 2017
    Date of Event
    November 15, 2017
    Report Date
    May 21, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK143336
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF A PHOTOGRAPH. VISUAL INSPECTION IS LIMITED, AND FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE PRODUCT NOT BEING RETURNED. IN THE PHOTOGRAPH PROVIDED, IT APPEARS THAT AT THE LEFT MANDIBLE THERE IS TISSUE OVERGROWTH SURROUNDING THE ARCH BAR. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO IMPROPER TECHNIQUE OF THE SURGEON BY NOT PROVIDING ADEQUATE SPACING BETWEEN THE BAR AND THE GINGIVA. THE INSTRUCTIONS FOR USE (IFU) FOR THIS PRODUCT HAS THE FOLLOWING INFORMATION IN THE SECTION TITLED DIRECTIONS FOR USE: 5. ONCE THE BAR IS SEATED IN THE LOCKING GROOVE OF THE SCREW, THE BAR HEIGHT OFF OF THE GINGIVA MAY BE ADJUSTED BY THE SURGEON AS THE SCREW CAN ROTATE WITHIN THE ARCH BAR SLOT. THE SURGEON SHOULD CONFIRM THAT FINAL PLACEMENT OF SCREW AND ARCH BAR DOES NOT COMPRESS THE GINGIVAL SOFT TISSUE AND ENSURE THAT THE SCREW / ARCH BAR ARE STILL ENGAGED. A SUMMARY OF THE INVESTIGATION WAS SENT TO THE COMPLAINANT CONVEYING PROPER SURGICAL TECHNIQUE AND USE OF THE DEVICE. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2017-00879-1.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). MEDICAL PRODUCT - ZIMMER BIOMET OMNIMAX SD XD SCREW 2.0 X 7 MM CATALOG #: 91-5707 LOT #:NI OR ZIMMER BIOMET OMNIMAX SD XD SCREW 2.0 X 9 MM CATALOG #: 91-5709 LOT #:NI. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION SINCE THE EVENT DID NOT LEAD TO A PREMATURE EXPLANTATION OF THE DEVICE. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2017-00879.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ENROLLED IN THE OMNIMAX TRIAL PRESENTED FOR THEIR SCHEDULED DEVICE REMOVAL WITH MUCOSAL OVERGROWTH AROUND TWO SCREWS ON THE LEFT MANDIBLE. THIS REQUIRED STAB INCISION FOR REMOVING THE SCREWS. THE SURGEON REPORTED THE INCISION "WILL HEAL WITHOUT ANY ADDITIONAL TREATMENT. NO FOLLOW-UP IS NEEDED." THE AVERAGE REMOVAL TIME IS 2.8 MINUTES. THE REMOVAL TIME FOR THIS CASE WAS TWO MINUTES AND FORTY-NINE SECONDS. IT IS NOTED THAT THIS IS NOT A MALFUNCTIONING OF THE DEVICE OR AN UNEXPECTED EVENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889690 OMNIMAX ARCH BAR PLATE, BONE JEY BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention