BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5MM SYSTEM 2 HOLE LONG STRAIGHT PLATE

    MDR report key: 7475336 · Received May 1, 2018

    Report

    Report Number
    0001032347-2018-00222
    Event Type
    Injury
    Date Received
    May 1, 2018
    Date of Event
    February 2, 2018
    Report Date
    September 26, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK121589
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. THE PATIENT HAD THESE IMPLANTS FOR MORE THAN THREE YEARS, HAD AN MRI ON (B)(6) 2018, AND DEVELOPED FLUID BUILDUP UNDERNEATH HER PLATE SIX DAYS LATER ON (B)(6) 2018. HOWEVER, THE PATIENT DID NOT RECEIVE ANY ADDITIONAL THERAPY OR SURGERY, AND A DEFINITIVE CAUSE COULD NOT BE DETERMINED BY HER PHYSICIANS. THE IMPLANTS REMAIN IMPLANTED; THEREFORE, FUNCTIONAL TESTING AND INSPECTIONS COULD NOT BE PERFORMED. THERE WAS LIMITED INFORMATION PROVIDED AND NO MATERIALS SUCH AS PHOTOGRAPHS, SCANS, X-RAYS, 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2018-00223-1.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET MICROFIXATION 1.5MM X 3.5MM HT SD X-DR SCREW CATALOG #: 91-6103 LOT #: NI. THERAPY DATE: (B)(6) 2018. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, IT REMAINS 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 REPORT: 0001032347-2018-00223.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT SHE HAD AN MRI AND SIX DAYS LATER DEVELOPED A BLEED UNDERNEATH THE PLATE. SHE INDICATED THAT SHE WAS HOSPITALIZED FOR TWO DAYS IN THE ICU AS A RESULT OF THE BLEED, BUT DID NOT UNDERGO ANY ADDITIONAL THERAPY OR SURGERY. SHE STATED HER DOCTORS INFORMED HER THAT THE BLEED MAY HAVE BEEN DUE TO DAMAGE TO SMALL VESSELS. THE PATIENT IS SCHEDULED TO HAVE A CT SCAN IN ORDER TO CONFIRM THAT THE BLEED IS RESOLVED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319430 1.5MM SYSTEM 2 HOLE LONG STRAIGHT PLATE BONE PLATE JEY BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization