BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: TRAUMA

    MDR report key: 17086437 · Received June 8, 2023

    Report

    Report Number
    8030965-2023-07295
    Event Type
    Injury
    Date Received
    June 8, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. D1, D2A, D2B, D3, D4, G4 ¿ 510K: THIS REPORT IS FOR AN UNKNOWN SCREWS: TRAUMA/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. E1: INITIAL REPORTER FACILITY ADDRESS: (B)(6). 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

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: RAMLY, E.P. ET AL (2019), COMPUTERIZED APPROACH TO FACIAL TRANSPLANTATION: EVOLUTION AND APPLICATION IN 3 CONSECUTIVE FACE TRANSPLANTS., PLASTIC AND RECONSTRUCTIVE SURGERY - GLOBAL OPEN, VOL. 7 (XX), PAGES 1-11 (USA). THE AIM OF THIS STUDY IS TO DYNAMICALLY INTEGRATE CSP, CAD/CAM, AND SURGICAL NAVIGATION. BETWEEN 2012 AND 2018, A TOTAL OF 3 MALES WERE INCLUDED IN THE STUDY. THREE CONSECUTIVE FTS WERE PERFORMED. CSP AND POSTOPERATIVE RESULTS WERE COMPARED USING COMPUTERIZED TOMOGRAPHY¿DERIVED CEPHALOMETRIC MEASUREMENTS, AND THE LITERATURE WAS REVIEWED. TWO FULL AND 1 PARTIAL FT WERE SUCCESSFULLY PERFORMED USING THE CSP PROTOCOL. CSP FACILITATED THE EXECUTION OF FT WITH MINOR ANGULAR AND TRANSLATIONAL CEPHALOMETRIC VARIATIONS ON IMMEDIATE POSTOPERATIVE IMAGING. THE DONOR UNDERWENT PLACEMENT OF TITANIUM INTERMAXILLARY FIXATION SCREWS (SYNTHES, INC., WEST CHESTER, PA.) TO FACILITATE SUBSEQUENT INTRAOPERATIVE SURGICAL NAVIGATION (INTELLECT CRANIAL NAVIGATION SOFTWARE; STRYKER NAVIGATION, KALAMAZOO, MICH.), AND CT DATA FOR BOTH SUBJECTS WERE UPLOADED TO THE SURGICAL MODELING SOFTWARE [SYNTHES PROPLAN CMF/SURGICASE CONNECT (MATERIALISE, LEUVEN, BELGIUM)] FOR CSP. THE DONOR AND RECIPIENT FACIAL SKELETONS WERE VIRTUALLY SUPERIMPOSED, AND OSTEOTOMIES WERE PLANNED. RECIPIENT-SPECIFIC CUTTING GUIDES WERE PREFABRICATED ACCORDINGLY AND STERILIZED FOR OPERATIVE USE. THE MEAN FOLLOW-UP PERIOD WAS UNKNOWN. THE FOLLOWING THE COMPLICATIONS REPORTED AS FOLLOWS: PATIENT 1 IS A 37-YEAR-OLD MAN WHO HAD SUSTAINED A BALLISTIC FACIAL INJURY SUBSEQUENTLY GRADUALLY DEVELOPED CLASS III MALOCCLUSION ON POSTOPERATIVE DAY (POD) 1 FOLLOWING FT. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT INVOLVES ONE UNK - SCREWS: TRAUMA. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276406 UNK - SCREWS: TRAUMA SCREW, FIXATION, BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Required Intervention