BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: MATRIXMIDFAC

    MDR report key: 24764260 · Received April 2, 2026

    Report

    Report Number
    8030965-2026-03068
    Event Type
    Injury
    Date Received
    April 2, 2026
    Date of Event
    October 29, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    JEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: MAURER M, RITZINGER K, GOTTSAUNER M, HAJ A, SCHEBESCH KM, KÜHNEL T, REICHERT T, ETTL T. SURGICAL TREATMENT OF FRONTAL SINUS FRACTURES: A RETROSPECTIVE EVALUATION OF 116 CASES. J CRANIOMAXILLOFAC SURG. 2025 DEC;53(12):2270-2278. DOI: 10.1016/J.JCMS.2025.10.011. EPUB 2025 OCT 29. PMID: 41168062. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS STUDY WAS TO PRESENT, RETROSPECTIVELY, THE INTERDISCIPLINARY SURGICAL MANAGEMENT OF FRONTAL SINUS FRACTURES IN A LEVEL-1 TRAUMA CENTER, AND TO EXAMINE THE DIFFERENT TREATMENT APPROACHES AS WELL AS THE RESULTING COMPLICATIONS. BETWEEN 2005 AND 2020, A TOTAL OF 116 PATIENTS WITH FRONTAL SINUS FRACTURES WERE SURGICALLY TREATED. THE MEAN AGE WAS 36.82 ± 17.27 YEARS. THE MAJORITY OF THE PATIENTS WERE MALE (N = 105, 90.5 %). THE MAIN CAUSES OF TRAUMA WERE TRAFFIC ACCIDENTS (N = 38, 32.8 %), FOLLOWED BY FALLS (N = 24, 20.7 %) AND SPORTS ACCIDENTS (N = 23, 19.8 %). OSTEOSYNTHESIS OF THE ANTERIOR TABLE WAS PERFORMED WITH TITANIUM PLATES (SYNTHES MATRIXMIDFACE¿; DEPUY SYNTHES, RAYNHAM, MA, USA). THE FOLLOW-UP PERIOD WAS AT LEAST 4 YEARS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SYNTHES TITANIUM PLATES. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: MATRIXMIDFACE (QTY 44). 10 PATIENTS (8.6 %) SHOWED SIGNS OF FRONTAL SINUSITIS OR PYOMUCOCELE IN THE FURTHER COURSE. THIS WAS SIGNIFICANTLY ASSOCIATED WITH POSTERIOR WALL DISLOCATION (P = 0.025), WITH DISLOCATION OF THE POSTERIOR WALL WITHOUT THERAPY (P = 0.003), AND WITH OBLITERATION OF THE FRONTAL SINUS (P = 0.028). NO INTERVENTION WAS MENTIONED. 6 PATIENTS (5.1 %) HAD POOR AESTHETIC OUTCOME WAS DOCUMENTED AND WAS SIGNIFICANTLY RELATED TO ACCOMPANYING NASOETHMOIDAL (P < 0.001) AND CENTROLATERAL (P = 0.001) FRACTURES. NO INTERVENTION WAS MENTIONED. 6 PATIENTS COMPLAINED OF PERSISTENT FRONTAL HEADACHE (5.1 %), WHICH WAS SIGNIFICANTLY INCREASED IN CASES OF ACCOMPANYING CRANIAL VAULT FRACTURES (P = 0.027). NO INTERVENTION WAS MENTIONED. 4 PATIENTS HAD POSTOPERATIVE CSF LEAKS (3.4 %), SIGNIFICANTLY ASSOCIATED WITH UNTREATED POSTERIOR WALL (P = 0.016), SKULL BASE RECONSTRUCTION BY PERICRANIAL FLAP (P < 0.001), AND ACCOMPANYING CENTROLATERAL FRACTURES (P < 0.001). NO INTERVENTION WAS MENTIONED. 1/2 (50.0 %) PATIENTS HAD FRONTAL SINUSITIS/PYOMUCOCELE IN ENDOSCOPIC APPROACH; NO INTERVENTION WAS MENTIONED. 2/33 (6.1 %) PATIENTS HAD PERSISTING FRONTAL HEADACHE IN CORONAL APPROACH; NO INTERVENTION WAS MENTIONED. 2/33 (6.1 %) PATIENTS HAD POOR AESTHETIC OUTCOME IN CORONAL APPROACH; NO INTERVENTION WAS MENTIONED. 1/17 (5.9 %) PATIENT HAD FRONTAL SINUSITIS/PYOMUCOCELE IN LACERATION APPROACH; NO INTERVENTION WAS MENTIONED. 1/17 (5.9 %) PATIENT HAD POOR AESTHETIC OUTCOME IN LACERATION APPROACH; NO INTERVENTION WAS MENTIONED. 1/21 (4.8 %) PATIENT HAD FRONTAL SINUSITIS/PYOMUCOCELE IN SUB-BROW APPROACH; NO INTERVENTION WAS MENTIONED. 3/21 (14.3 %) PATIENTS HAD PERSISTING FRONTAL HEADACHE IN SUB-BROW APPROACH; NO INTERVENTION WAS MENTIONED. 3/11 (46.4 %) PATIENTS HAD OCCURRENCE OF SINUSITIS IN FRACTURES OF BOTH THE ANTERIOR AND THE POSTERIOR TABLE AND PYOMUCOCELE WAS SIGNIFICANTLY INCREASED FOR NON-TREATMENT; NO INTERVENTION WAS MENTIONED. 2/3 (66.6 %) PATIENTS HAD OBLITERATION IN FRACTURES OF BOTH THE ANTERIOR AND THE POSTERIOR TABLE; NO INTERVENTION WAS MENTIONED. 1 CASE OF POST-THERAPEUTIC SINUSITIS IN THE SIX ISOLATED FRACTURES OF THE POSTERIOR WALL; NO INTERVENTION WAS MENTIONED. 1 CASE OF PERSISTING FRONTAL HEADACHE WAS OBSERVED IN 43 FRACTURES WITH INVOLVEMENT OF THE POSTERIOR TABLE; NO INTERVENTION WAS MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2005 UNK - CONSTRUCTS: MATRIXMIDFAC PLATE, BONE JEY SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention