BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TMJ SYSTEM CROSS-DRIVE FOSSA SCREW, 2.0 X 9 MM

    MDR report key: 8052640 · Received November 8, 2018

    Report

    Report Number
    0001032347-2018-00761
    Event Type
    Malfunction
    Date Received
    November 8, 2018
    Report Date
    March 26, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    K910038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO PRODUCT WAS RETURNED, THEREFORE NO FUNCTIONAL TESTS OR INSPECTIONS COULD BE PERFORMED. NO X-RAYS, SCANS, PICTURES, OR PHYSICIAN'S REPORTS WERE PROVIDED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT 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). MEDICAL PRODUCT: BIOMET MICROFIXATION TMJ SYSTEM RIGHT STANDARD MANDIBULAR COMPONENT CATALOG #: 24-6545, LOT #: 183570, BIOMET MICROFIXATION TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT, SMALL CATALOG #: 24-6546, LOT #: 174120, BIOMET MICROFIXATION TMJ SYSTEM RIGHT FOSSA COMPONENT, SMALL CATALOG #: 24-6562, LOT #: 216350, BIOMET MICROFIXATION TMJ SYSTEM LEFT FOSSA COMPONENT, SMALL CATALOG #: 24-6563, LOT #: 190720, BIOMET MICROFIXATION "2.4MM" SYSTEM HT CROSS-DRIVE SCREW, 2.7X10MM CATALOG #: 91-2710, LOT #: NI, BIOMET MICROFIXATION "2.4MM" SYSTEM HT CROSS-DRIVE SCREW, 2.7X12MM CATALOG #: 91-2712, LOT #: NI, BIOMET MICROFIXATION TMJ SYSTEM CROSS DRIVE FOSSA SCREW, 2.0X7MM CATALOG #: 99-6577, LOT #: NI. THERAPY DATE: UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, IT REMAINS IMPLANTED. 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 REPORTS: 0001032347-2018-00754, 0001032347-2018-00755, 0001032347-2018-00756, 0001032347-2018-00757, 0001032347-2018-00758, 0001032347-2018-00759, AND 0001032347-2018-00760.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT "HER RIGHT IMPLANT IS DISLOCATED AND HAS BONE OVERGROWTH AND THE LEFT SIDE HAS BONE FRAGMENTS". NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890684 TMJ SYSTEM CROSS-DRIVE FOSSA SCREW, 2.0 X 9 MM BONE SCREW JEY BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1