BEUDAMED
    FDA Adverse Event Injury Summary report: N

    "2.4MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW

    MDR report key: 7484591 · Received May 3, 2018

    Report

    Report Number
    0001032347-2018-00235
    Event Type
    Injury
    Date Received
    May 3, 2018
    Report Date
    October 26, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    PMA / PMN Number
    PK001238
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    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 AND NO FUNCTIONAL TESTS OR INSPECTIONS COULD BE PERFORMED. NO X-RAYS, SCANS, PICTURES, OR PHYSICIAN'S REPORTS WERE PROVIDED. FOR AFOREMENTIONED REASONS, THE COMPLAINT CANNOT BE VERIFIED. THE MANUFACTURING HISTORY FOR THE TMJ COMPONENTS WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED FOR THE SCREWS AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. THE MOST LIKELY CAUSE OF THE COMPLAINT IS DUE TO THE REPORTED ECTOPIC BONE GROWTH, WHICH IS LIMITING THE PATIENT'S MOVEMENT AND OPENING. THE INSTRUCTIONS FOR USE (IFU) FOR THIS PRODUCT WARNS OF THE POTENTIAL FOR COMPLICATIONS. IT STATES IN THE SECTION TITLED ADVERSE EVENTS: HETEROTOPIC BONE FORMATION. THE IFU ALSO STATES IN THE SECTION TITLED PATIENT COUNSELING INFORMATION: DISCUSSION OF THE FOLLOWING POINTS IS RECOMMENDED PRIOR TO SURGERY. THE RISKS ASSOCIATED WITH A TOTAL TMJ SYSTEM (SEE WARNINGS AND ADVERSE EVENTS). POST-OPERATIVE PAIN RELIEF AND RETURN OF FUNCTION VARIES FROM PATIENT TO PATIENT. 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 REPORTS: 0001032347-2018-00233-1, 0001032347-2018-00234-1, 0001032347-2018-00236-1, 0001032347-2018-00237-1, AND 0001032347-2018-00238-1.

    Description of Event or Problem · 0

    THE SURGEON'S OFFICE REPORTED THE LAST TIME THE PATIENT WAS IN THE OFFICE WAS MARCH OF 2017. AT THAT TIME THE SURGEON DID DISCUSS REMOVAL OF ECTOPIC BONE WITH THE PATIENT AS SHE HAD LIMITED MOVEMENT AND OPENING. HOWEVER, THE PATIENT HAS NOT BEEN SEEN SINCE THAT APPOINTMENT. SHE HAS A RIGHT SIDE PROSTHESIS ONLY. THE OFFICE IS NOT AWARE IF THE PATIENT IS BEING TREATED BY ANOTHER PROVIDER.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: BIOMET MICROFIXATION TMJ SYSTEM RIGHT FOSSA COMPONENT, SMALL CATALOG #: 24-6562 LOT #: 414130C, BIOMET MICROFIXATION TMJ SYSTEM RIGHT STANDARD OFFSET MANDIBULAR COMPONENT CATALOG #: 24-6645 LOT #: 332200B, BIOMET MICROFIXATION 2.4MM SYSTEM HIGH TORQUE CROSS-DRIVE SCREW CATALOG #: 91-2712 LOT #: NI, BIOMET MICROFIXATION TMJ SYSTEM CROSS DRIVE FOSSA SCREW CATALOG #: 99-6577 LOT #: NI, BIOMET MICROFIXATION TMJ SYSTEM CROSS DRIVE EMERGENCY FOSSA SCREW CATALOG #: 99-6587. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, THE DEVICES REMAIN IMPLANTED IN THE PATIENT. 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: 0001032347-2018-00233 THROUGH 0001032347-2018-00238.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT A REVISION IS PLANNED DUE TO BONE GROWTH. SHE STATED SHE'S "NOT TOO HAPPY BECAUSE THE SURGEON HAS TO GO BACK IN AND CLEAN UP SOME BONE OVERGROWTH AND SHE SAID SHE DIDN'T KNOW THAT THAT WAS SOMETHING THAT COULD HAPPEN." NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326830 "2.4MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW BONE SCREW HWC BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R