BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM MADE DEVICE GAI LEFT PM-TMJ & MODEL

    MDR report key: 7658584 · Received July 3, 2018

    Report

    Report Number
    0001032347-2018-00428
    Event Type
    Injury
    Date Received
    July 3, 2018
    Date of Event
    June 6, 2018
    Report Date
    December 14, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    PN/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE DESIGN. THE DESIGN VENDOR CONDUCTED AN INVESTIGATION INTO THE COMPLAINT, THEIR INVESTIGATION REPORT STATES: THE MANDIBULAR COMPONENT WAS REVISED PER SURGEON REQUEST ON (B)(6) 2018 AND APPROVED ON (B)(6) 2018. THE INITIAL IMPLANT FOLLOWED THE CONTOUR OF THE PATIENT¿S ANATOMY AND INCLUDED A BEND NEAR THE POSTERIOR OF THE MANDIBLE. A MANDIBLE MARKING GUIDE WAS DESIGNED TO AID IN THE REMOVAL OF THE PATIENT¿S LEFT CONDYLE AND MARK SCREW LOCATIONS FOR THE FINAL IMPLANT. THE REVISED MANDIBULAR IMPLANT DESIGN CONTAINED A GAP BETWEEN THE IMPLANT AND PATIENT¿S ANATOMY TO ALLOW THE SURGEON TO RELOCATE THE EXISTING BONE GRAFT. THE MANDIBLE MARKING GUIDE DESIGN WAS NOT ALTERED SINCE THE CONDYLE RESECTION AND FIXATION MARKINGS REMAINED THE SAME. THE IMPLANT WAS MODIFIED TO LEAVE A GAP BETWEEN THE BONE AND THE EXISTING BONE GRAFT IN ORDER SO THAT THE SURGEON COULD MODIFY THE GRAFT. THE DESIGN VENDOR DETERMINED THAT THERE WAS NO NEED TO MODIFY THE CUTTING GUIDES SINCE THE CONDYLE RESECTION AND FIXATION MARKINGS REMAINED THE SAME. THE GUIDE COULD HAVE STILL BEEN USED IF THE MARKS WERE MADE PRIOR TO THE GRAFT ADJUSTMENT. HOWEVER, IF THE GUIDES WERE USED POST-MODIFICATION OF THE GRAFT, THE ORIGINAL DESIGN WOULD INTERFERE WITH THE FIT OF THE GUIDE AND WOULD HAVE TO BE CUT TO FIT. THE DESIGN VENDOR DID NOT RELAY THIS INFORMATION TO THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO MISCOMMUNICATION BETWEEN THE DESIGN VENDOR AND THE CUSTOMER. 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. DEVICE EVALUATED BY MANUFACTURER AND NOT RETURNED TO MANUFACTURER.

    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). REPORT SOURCE: FOREIGN COUNTRY - (B)(6). THIS PRODUCT IS MANUFACTURED BY BIOMET MICROFIXATION AND 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 UNITED STATES UNDER PMA NUMBER P020016. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 CUTTING GUIDE OF THE MANDIBULAR DOESN¿T MATCH THE IMPLANT. THE SURGEON HAD TO CUT THE MANDIBULAR GUIDE INTO THREE PARTS. THE SURGEON REQUESTED A REVISION TO THE ORIGINAL DESIGN, THE ACTUAL IMPLANT WAS ADJUSTED; HOWEVER THE CUTTING GUIDE WAS THE ORIGINAL DESIGN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499706 CUSTOM MADE DEVICE GAI LEFT PM-TMJ & MODEL JOINT, TEMPOROMANDIBULAR, IMPLANT LZD BIOMET MICROFIXATION N/A 832700A

    Patients

    Seq Age Sex Outcome Treatment
    1