BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0/1.0 4 HOLE REG

    MDR report key: 11888686 · Received May 26, 2021

    Report

    Report Number
    0001032347-2021-00309
    Event Type
    Injury
    Date Received
    May 26, 2021
    Date of Event
    May 7, 2021
    Report Date
    January 12, 2022
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    K121589
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: FOUR 3D REFORMATTED IMAGES OF THE LEFT MANDIBULAR CONDYLE DEMONSTRATE MALLEABLE PLATE AND SCREW FIXATION DEVICES WHICH APPEAR TO BE FRACTURED. NO TMJ DISLOCATION. 3D IMAGES WERE PROVIDED. REVIEW OF THE IMAGES CONFIRMED THE IMPLANT FRACTURE. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, LOT IDENTIFICATION WAS NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 2.0/1.0 4 HOLE REG CAT# 01-9204 LOT# NI. 2.0X7MM HT SD X-DR SCR EA CAT#: 91-6207 LOT#:NI - QTY: 8. REPORT SOURCE: (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SEGMENT REVISION PROCEDURE APPROXIMATELY 2 MONTHS POSTIMPLANTATION DUE TO 2 FRACTURED PLATES. THE PATIENT¿S YAWN HAD PRODUCED A LARGE NOISE ACCOMPANIED BY INTENSE PAIN IN THE REGION OF THE LEFT CONDYLE. BOTH PLATES WERE REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784660 2.0/1.0 4 HOLE REG PLATE, FIXATION, BONE JEY BIOMET MICROFIXATION N/ NI

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Hospitalization| R