BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HTR-PMI S.B.1998-191216 LEFT FRONTAL TEMPORAL PARIETAL IMPLANT

    MDR report key: 9920605 · Received April 3, 2020

    Report

    Report Number
    0001032347-2020-00199
    Event Type
    Malfunction
    Date Received
    April 3, 2020
    Report Date
    September 16, 2020
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    KKY
    UDI-DI
    00841036279875
    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. THE COMPLAINT IS CONFIRMED. NO PRODUCT WAS RETURNED, AS IT WAS REPORTED THE IMPLANT WAS MODIFIED TO COMPLETE THE PROCEDURE. NO X-RAYS, SCANS, PICTURES, OR PHYSICIAN'S REPORTS WERE PROVIDED. THE DESIGN VENDOR AND MANUFACTURER OF THIS DEVICE WAS NOTIFIED OF THE FIT ISSUE AND PERFORMED AN INVESTIGATION AND PROVIDED THEIR RESULTS. THE DESIGN VENDOR FOUND THAT THE IMPLANT MET ALL PRODUCT REQUIREMENTS OF A STANDARD FIT + 0.75MM IMPLANT, AS REQUESTED ON THE DESIGN INPUT FORM. THE DESIGN VENDOR FOUND THAT THE THICKNESS IN CERTAIN PORTIONS OF THE TEMPORALIS REGION WAS GREATER THAN 6MM. IT WAS STATED THAT THE THICKNESS OF THIS REGION COULD HAVE BEEN REDUCED MORE TO ACCOMMODATE PREFERENCES, BUT THE IMPLANT WAS MANUFACTURED APPROPRIATELY PER THE INSTRUCTIONS. THE DHR WAS REVIEWED, NO NON-CONFORMANCES WERE FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. FOR PATIENT MATCHED HTR-PMI IMPLANTS (PMXXXXXX) IN THE PREVIOUS YEAR (FROM THE NOTIFICATION DATE) REGARDING FIT ISSUES WITH THE IMPLANT, THE CALCULATED COMPLAINT RATE IS 1.07% WHICH IS NO GREATER THAN THE OCCURRENCE LISTED IN THE APPLICATION FMEA. THE ROOT CAUSE OF THIS COMPLAINT WAS DETERMINED TO BE OUTSIDE THE SCOPE OF THE DESIGN/MANUFACTURING PROCESS. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CUSTOM CRANIAL IMPLANT WAS TOO LARGE IN AN AREA AND TEMPORALLY IT WAS TOO THICK. THE IMPLANT WAS MODIFIED INTRAOPERATIVELY AND SUCCESSFULLY IMPLANTED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT REMAINS 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 THERE WAS AN UNSPECIFIED FIT ISSUE WITH A CUSTOM CRANIAL IMPLANT. THE IMPLANT WAS MODIFIED INTRAOPERATIVELY AND SUCCESSFULLY IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389062 HTR-PMI S.B.1998-191216 LEFT FRONTAL TEMPORAL PARIETAL IMPLANT CUSTOM MADE DEVICE KKY BIOMET MICROFIXATION N/A 963150 00841036279875

    Patients

    Seq Age Sex Outcome Treatment
    1