BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HTR*PMI K.V.1962-200720 RIGHT FRONTAL TEMPORAL PARIETAL IMPLANT

    MDR report key: 10653586 · Received October 8, 2020

    Report

    Report Number
    0001032347-2020-00504
    Event Type
    Malfunction
    Date Received
    October 8, 2020
    Date of Event
    September 9, 2020
    Report Date
    April 15, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    KKY
    UDI-DI
    00888233029155
    PMA / PMN Number
    K924935
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PHOTOS OF THE DEFECT WERE PROVIDED, WHICH APPEARS TO SHOW A GAP IN BETWEEN THE IMPLANT AND THE PATIENT'S SKULL. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE INVESTIGATION FROM THE MANUFACTURER NOTED THAT THERE WERE NO DESIGN/MANUFACTURING PROCESS ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS IMPLANTED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. REPORT SOURCE ¿ (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOM CRANIOPLASTY PLATE WAS TOO SMALL AND DID NOT FIT AS DESIRED. THE SURGEON HAD TO USE BONE CEMENT IN THE CAUDAL AREA OF THE DEFECT IN ORDER TO COMPLETELY REPAIR THE DEFECT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118188 HTR*PMI K.V.1962-200720 RIGHT FRONTAL TEMPORAL PARIETAL IMPLANT CUSTOM MADE DEVICE KKY BIOMET MICROFIXATION N/A 999360 00888233029155

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR