BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HTR*PMI GREB RIGHT MANDIBULAR IMPLANT

    MDR report key: 9512804 · Received December 23, 2019

    Report

    Report Number
    0001032347-2019-00558
    Event Type
    Injury
    Date Received
    December 23, 2019
    Report Date
    March 23, 2020
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    K924935
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT IS CONFIRMED. THE DESIGN VENDOR AND MANUFACTURER OF THESE PARTS (CAS) WAS NOTIFIED OF THE FIT AND CRACKING ISSUES AND PERFORMED AN INVESTIGATION AND PROVIDED THEIR RESULTS. THE DESIGN VENDOR DID NOT FIND ANY EVIDENCE THAT THE DESIGN OR MANUFACTURING OF THIS PART CONTRIBUTED TO THE FIT OR CRACKING ISSUES EXPERIENCED. AN IMAGE WAS PROVIDED, WHICH SHOWED ONE OF THE CRACKED IMPLANTS. THE DHRS FOR THESE PRODUCTS WERE REVIEWED, AND NO NON-CONFORMANCES WERE FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. FOR PATIENT MATCHED HTR-PMI IMPLANTS (PMXXXXXX) AND THE PREVIOUS YEAR (FROM THE NOTIFICATION DATE) REGARDING INTRAOPERATIVE CRACKING OF THE IMPLANT, THERE IS A COMPLAINT RATE IS (B)(4) WHICH IS NO GREATER THAN THE OCCURRENCE LISTED IN THE APPLICATION FMEA. FOR PATIENT MATCHED HTR-PMI IMPLANTS (PMXXXXXX) AND THE PREVIOUS YEAR (FROM THE NOTIFICATION DATE) REGARDING FIT ISSUES, THERE IS A COMPLAINT RATE IS (B)(4) WHICH IS NO GREATER THAN THE OCCURRENCE LISTED IN THE APPLICATION FMEA. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED. UPON REVIEW OF THE PROVIDED INTRA-OPERATIVE PICTURE, IT APPEARS THE THREE SCREWS SHOWN WERE INSERTED INTO THE IMPLANT ON AN ANGLE, RATHER THAN DIRECTLY PERPENDICULAR INTO THE IMPLANT. IT ALSO APPEARS THAT THE SCREWS WERE INSERTED CLOSE TO THE EDGES OF THE IMPLANT. IT IS POSSIBLE THAT THESE ISSUES CONTRIBUTED TO THE FAILURES OF THE DEVICES. 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. THE FOLLOWING FIELDS WERE UPDATED: DATE OF THIS REPORT, DESCRIBE EVENT OR PROBLEM, EXPIRATION DATE, DEVICE AVAILABILITY, DATE RECEIVED BY MANUFACTURER, TYPE OF REPORT, FOLLOW UP TYPE, DEVICE EVALUATED BY MANUFACTURER, DEVICE MANUFACTURE DATE, METHOD CODE, RESULTS CODE, CONCLUSIONS CODE, AND ADDITIONAL NARRATIVES/DATA.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2019-00556, 0001032347-2019-00557. CONCOMITANT MEDICAL PRODUCTS: HTR*PMI GREB LEFT MANDIBULAR IMPLANT, PART# PM622502, LOT# 937360, HTR*PMI GREB CHIN IMPLANT, PART# PM622504, LOT# 937350, HTR*PMI GREB RIGHT MANDIBULAR IMPLANT, PART# PM622505, LOT# 937340. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. REPORT SOURCE: FOREIGN COUNTRY: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CUSTOM MANDIBLE IMPLANT FRACTURED UPON IMPLANTATION AND THAT A CUSTOM CHIN IMPLANT HAD TO BE ALTERED DUE TO FIT ISSUES. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1303600 HTR*PMI GREB RIGHT MANDIBULAR IMPLANT CUSTOM DEVICE LZD BIOMET MICROFIXATION N/A 937340

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SEE H10 NARRATIVE