BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: MAXILLOFACIAL

    MDR report key: 15710031 · Received November 1, 2022

    Report

    Report Number
    8030965-2022-09184
    Event Type
    Injury
    Date Received
    November 1, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. THIS REPORT IS FOR AN UNKNOWN SCREWS: MAXILLOFACIAL/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: SCHMIDT BL, ET AL. (1988), THE REMOVAL OF PLATES AND SCREWS AFTER LE FORT I OSTEOTOMY, J ORAL MAXILLOFAC SURG, VOLUME 56, PAGES 18, 184-188, (USA) . THIS STUDY IS A RETROSPECTIVE CHART REVIEW DESIGNED TO EVALUATE THE INCIDENCE AND REASONS FOR REMOVAL OF PLATES AND SCREWS AFTER LE FORT I OSTEOTOMY. BETWEEN DECEMBER 1985 AND DECEMBER 1994, 190 PATIENTS WHO UNDERWENT LE FORT I OSTEOTOMY WERE INCLUDED IN THE STUDY. THERE WERE 118 FEMALES AND 72 MALES WITH A MEAN AGE OF 25.42 + 9.49 YEARS. A TOTAL OF 738 PLATES WERE IMPLANTED WHICH INCLUDED 423 UNKNOWN SYNTHES 2.0 MM MAXILLOFACIAL TITANIUM PLATES AND SCREWS, 253 COMPETITOR¿S VITALLIUM PLATES AND COMPETITOR¿S 56 STAINLESS PLATES. THE AVERAGE FOLLOW-UP TIME WAS 28.6 MONTHS (RANGE, 2 MONTHS TO 7.7 YEARS). COMPLICATIONS WERE REPORTED AS FOLLOWS: A TOTAL OF 13.2 PERCENT OF UNKNOWN SYNTHES TITANIUM PLATES WERE REMOVED BECAUSE THE PATIENTS EITHER REQUESTED REMOVAL OR THEY REQUIRED REMOVAL SECONDARY TO COMPLICATIONS RELATED TO THE PLATES OR SCREWS SUCH AS PALPATION, SINUSITIS, INFECTION, PAIN, AND TEMPERATURE SENSITIVITY. IN EACH CASE OF HARDWARE REMOVAL, IT CONSTITUTED ADEQUATE MANAGEMENT, AND THE SYMPTOMS RESOLVED. THIS REPORT IS FOR THE UNKNOWN SYNTHES 2.0 MM MAXILLOFACIAL TITANIUM PLATES AND SCREWS. A COPY OF THE CLINICAL EVALUATION FORM IS BEING SUBMITTED WITH THIS REGULATORY REPORT. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458032 UNK - SCREWS: MAXILLOFACIAL SCREW,FIXATION,BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention