BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM MADE DEVICE HEDELUND LEFT PM-TMJ & MODEL

    MDR report key: 8416363 · Received March 13, 2019

    Report

    Report Number
    0001032347-2019-00164
    Event Type
    Malfunction
    Date Received
    March 13, 2019
    Date of Event
    February 13, 2019
    Report Date
    July 22, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PRE-OPERATIVE AND POST-OPERATIVE SCANS. AS THE REPORT MENTIONED, THE PRE-OPERATIVE SCAN WAS TAKEN (B)(6) 2017 AND THE SURGERY WAS PERFORMED (B)(6) 2018. THE DESIGN VENDOR CONFIRMED THAT THERE WERE CHANGES TO THE PATIENTS ANATOMY BETWEEN THE PRE-OPERATIVE AND POST-OPERATIVE SCANS, CAUSING THE FOSSA THAT WAS DESIGNED OF THE PRE-OPERATIVE SCANS TO NOT FIT THE ANATOMY OF THE PATIENT. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO CHANGES IN THE PATIENT'S ANATOMY AFTER THE PRE-OPERATIVE SCANS WERE TAKEN. A SUMMARY OF THE INVESTIGATION WAS SENT TO THE COMPLAINANT CONVEYING PROPER SURGICAL TECHNIQUE AND USE OF THE DEVICE. 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

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). IMPLANT DATE: (B)(6) 2018. PMA/510(K) NUMBER: THIS PRODUCT IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS BIOMET MICROFIXATION MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE U.S. UNDER PMA NUMBER P020016. (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE IMPLANT IS NOT CORRECT. THE IMPLANT DOES NOT FIT AND THE MANDIBLE PART IS NOT LONG ENOUGH TO MEET THE FOSSA IMPLANT. THIS WAS DETERMINED POST OPERATIONAL. THE SURGEON IS EVALUATING IF THERE MIGHT BE ANOTHER FOSSA PRODUCED AND IMPLANTED. THE PATIENT HAS MALOCCLUSION. THE PATIENT HAS NO PAIN, BUT THE MIDLINE IS OFF. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210316 CUSTOM MADE DEVICE HEDELUND LEFT PM-TMJ & MODEL CUSTOM MADE TMJ LZD BIOMET MICROFIXATION N/A 874050A

    Patients

    Seq Age Sex Outcome Treatment
    1