BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0/1.0 4 HOLE MED

    MDR report key: 7107582 · Received December 12, 2017

    Report

    Report Number
    0001032347-2017-00852
    Event Type
    Injury
    Date Received
    December 12, 2017
    Date of Event
    August 10, 2017
    Report Date
    April 2, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK121589
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT IS CONSIDERED CONFIRMED AS IT WAS REPORTED A REVISION OCCURRED. PRODUCT IDENTITIES COULD NOT BE CONFIRMED DUE TO THE PRODUCTS NOT BEING RETURNED. VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE CONFIRMED AS A RESULT OF THE PRODUCTS NOT BEING RETURNED. AS PER THE COMPLAINT FORM, A REVISION WAS SCHEDULED FOR (B)(6) 2017 AND THE PRODUCT DISPOSITIONS WERE MARKED AS "SCRAPPED" INDICATING THAT THE REVISION WAS PERFORMED. IT WAS REPORTED THAT, "THE SURGEON STATED THAT THIS EVENT WAS RELATED TO THE UNDERLYING DISEASE OF A PATIENT." NO ADDITIONAL INFORMATION WAS SUBMITTED AS TO WHAT THE SPECIFIC CONDITION WAS, BUT THERE WAS NO REPORTED ALLEGED MALFUNCTION OF THE IMPLANTS. THE DEVICE HISTORY RECORDS FOR THESE PRODUCTS WERE REVIEWED AND NO NON-CONFORMANCES WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO PATIENT CONDITION. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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: 0001032347-2017-00849-1, 0001032347-2017-00850-2, AND 0001032347-2017-00851-1, .

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT - ZIMMER BIOMET 1.5 PLATE CATALOG #: 01-7040-K, LOT #: 000500, ZIMMER BIOMET 1.5 PLATE; CATALOG #: 01-7040-K LOT #: 023140, ZIMMER BIOMET 2.0 PLATE; CATALOG #: 01-9233 LOT #: 927880, UNKNOWN SCREWS; CATALOG #: NI, LOT #: NI, THERAPY DATE - (B)(6) 2017. (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, IT WAS DISCARDED. 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: 0001032347-2017-00849, 0001032347-2017-00850, AND 0001032347-2017-00851.

    Description of Event or Problem · 1

    IT WAS REPORTED EIGHT DAYS POST OPERATIVE, THE IMPLANTED PLATE IN THE PATIENT'S MAXILLA WAS EXPOSED THROUGH THE SKIN. THE SURGEON STATED THAT THIS EVENT WAS RELATED TO THE UNDERLYING DISEASE OF A PATIENT. A REVISION WAS SCHEDULED, IT HAS NOT BEEN CONFIRMED IF THE REVISION OCCURRED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. THE SCREW PART NUMBERS WERE NOT REPORTED; ZIMMER BIOMET REQUESTED ADDITIONAL INFORMATION ON THESE DEVICES FROM CUSTOMER; HOWEVER, A RESPONSE HAS NOT YET BEEN RECEIVED. IF THIS INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889347 2.0/1.0 4 HOLE MED PLATE, FIXATION, BONE JEY BIOMET MICROFIXATION N/A 827410

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R