BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HTR-PMI CT77-210906 RIGHT FRONTAL PARIETAL IMPLANT

    MDR report key: 12697218 · Received October 26, 2021

    Report

    Report Number
    0001032347-2021-00488
    Event Type
    Malfunction
    Date Received
    October 26, 2021
    Report Date
    March 17, 2022
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    KKY
    UDI-DI
    00888233047180
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE HTR-PMI CT77-210906 RT FT PA (ITEM# PM624480, LOT# 069020) WAS RETURNED FOR INVESTIGATION. COMPARISON BETWEEN THE PHYSICAL IMPLANT AND THE DESIGN SHOWN IN THE DHR CONFIRMED THAT THE IMPLANT RECEIVED DID NOT MATCH THE PATIENT'S DEFECT. VISUAL INSPECTION SHOWS THAT THE IMPLANTS WERE RETURNED AND UNOPENED. ITEM AND LOT NUMBERS ARE CONFIRMED TO MATCH THE COMPLAINT FROM THE LABELS. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO A PACKAGING ISSUE. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INCORRECT IMPLANT WAS IN THE PACKAGE. THE ISSUE WAS DISCOVERED PRIOR TO THE IMPLANT BEING SENT TO THE HOSPITAL, THEREFORE THERE WAS NO PATIENT IMPACT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1599949 HTR-PMI CT77-210906 RIGHT FRONTAL PARIETAL IMPLANT CUSTOM MADE DEVICE KKY BIOMET MICROFIXATION N/A 069020 00888233047180

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown