BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITANIUM CONDYLAR HEAD

    MDR report key: 19587685 · Received June 21, 2024

    Report

    Report Number
    8030965-2024-07785
    Event Type
    Malfunction
    Date Received
    June 21, 2024
    Date of Event
    May 24, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    NEI
    PMA / PMN Number
    K063181
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. D10 THERAPY DATE: (B)(6) 2024. H3, H4, H6: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON MAY 24, 2024, THIS WAS A MANDIBLE RECON CASE WITH FIBULA FLAP. IT WAS A COMBINED PLANNING CASE WITH MATERIALISE FOR CUTTING GUIDES AND PLANNING, AND DPS FOR A MILLED PSPM PLATE. THE SURGEONS STATE THAT THE PLATE DID NOT FIT CORRECTLY, IT WAS TOO LONG AND TOO POSTERIOR TO THE RAMUS WHEN ATTACHED TO THE FIBULA BONE SEGMENTS WITH THE CONDYLAR HEAD ADD-ON ATTACHMENT. THE SURGEONS HAD TO MAKE SOME INTRAOPERATIVE AMENDMENTS TO THE PLAN AND THE RESIDUAL MANDIBLE TO GET IT TO FIT PROPERLY. THE SURGEON FEEDBACK IS THAT PERHAPS THE CUTTING GUIDE ON THE MANDIBLE WAS NOT POSITIONED CORRECTLY. IN THIS CASE THE SURGEONS COULD ONLY LENGTHEN, WHICH LIMITED THE OPTIONS. HOWEVER, THE SUSPECTED PROBLEM HAS ORIGINATED FROM THE CUTTING GUIDE ON THE MANDIBLE BEING SLIGHTLY ROTATED, WHICH CAUSED THE PLATE TO FLARE EITHER LATERAL OR POSTERIORLY AT THE CONDYLAR END. A SMALL DISCREPANCY IN ANGULATION AT THE FRONT RESULTS IN A LARGE DISCREPANCY POSTERIORLY. OF NOTE, THE FIELD OF VIEW WAS CUT OFF AT THE CONDYLES SO THAT THE FOSSA ONLY PARTIALLY APPEARED. THE RISK OF DISCREPANCY IN MEASUREMENTS WAS DISCUSSED WITH THE SURGEONS AND THEY AGREED TO PROCEED. ALSO THE MANDIBLE WAS SCANNED WITH THE CONDYLE OUT OF THE FOSSA. THERE WAS A SURGICAL DELAY OF 30 TO 45 MINUTES. THE SURGEONS HAD TO GO "OFF PLAN" TO FIT THE PLATE IN THE CORRECT POSITION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT IS GOOD, FOLLOWING USUAL POST-OPERATIVE COURSE. THE PATIENT DOES NOT SHOW SIGNS OF DEVELOPING INFECTION. IT IS UNKNOWN IF ANY FURTHER SURGERIES WILL BE NEEDED AT THIS TIME. THIS REPORT INVOLVES ONE (1) TITANIUM CONDYLAR HEAD. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2178250 TITANIUM CONDYLAR HEAD PROSTHESIS, CONDYLE, MANDIBULAR, TEMPORARY NEI SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Unknown CMD PATIENT SPECIFIC PLATE F/MANDIB MATM| FIXATION-PL F/CONDYL-HEAD ADD-ON POSITIO| MATRIXMANDIBLE SET SCREW F/CONDYL-HEAD A| MATRIXMANDIBLE SET SCREW F/CONDYL-HEAD A| PATIENT SPECIFIC GUIDE MANDIBLE