BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: MATRIXRIB PLATE/SCREWS

    MDR report key: 23544896 · Received November 13, 2025

    Report

    Report Number
    8030965-2025-11380
    Event Type
    Injury
    Date Received
    November 13, 2025
    Date of Event
    August 25, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. H11 ADDITIONAL NARRATIVE: ADDED: D4 (CATALOG). H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. H3, H6: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. 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 COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: HOEPELMAN RJ, BEERES FJP, BEKS RB, SWEET AAR, IJPMA FF, LANSINK KWW, VAN WAGENINGEN B, TROMP TN, LINK BC, VAN VEELEN NM, HOOGENDOORN JM, DE JONG MB, VAN BAAL MCP, LEENEN LPH, GROENWOLD RHH, HOUWERT RM. NON-OPERATIVE VS. OPERATIVE TREATMENT FOR MULTIPLE RIB FRACTURES AFTER BLUNT THORACIC TRAUMA: A MULTICENTER PROSPECTIVE COHORT STUDY. EUR J TRAUMA EMERG SURG. 2023 FEB;49(1):461-471. DOI: 10.1007/S00068-022-02093-9. EPUB 2022 AUG 25. PMID: 36008560; PMCID: PMC9925506. OBJECTIVE/METHODS/STUDY DATA: THE PURPOSE OF THIS PROSPECTIVE MULTICENTER OBSERVATIONAL STUDY WAS TO COMPARE RIB FIXATION WITH NON OPERATIVE TREATMENT IN PATIENTS WITH MULTIPLE RIB FRACTURES WITHOUT A FLAIL CHEST. BETWEEN JANUARY 2018 TO MARCH 2021, A TOTAL OF 927 PATIENTS WITH MULTIPLE RIB FRACTURES WERE INCLUDED IN ALL PARTICIPATING CENTERS. IN THE THREE HOSPITALS THAT PERFORMED RIB FIXATION, 80 (14%) OUT OF 591 UNDERWENT RIB FIXATION. FROM THE NONOPERATIVE CENTERS, ON AVERAGE 71 PATIENTS WERE ADEQUATELY MATCHED AFTER PROPENSITY SCORE MATCHING FROM THE IMPUTED DATA SETS. THE PATIENTS IN RIB FIXATION GROUP WERE TREATED SURGICALLY USING RIB FIXATION DEVICES, LIKELY INCLUDING SYSTEMS LIKE MATRIXRIB BY DEPUY SYNTHES, DETAILED DESCRIPTION OF THE METHODS AND SURGICAL PROCEDURES USED IN THIS STUDY IS AVAILABLE IN THE PUBLISHED STUDY PROTOCOL. 1-YEAR FOLLOW-UP WAS COMPLETED FOR 82% OF PATIENTS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: MATRIXRIB SYSTEM. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: MATRIXRIB PLATE/SCREWS (QTY: 27): (N=22) PATIENTS EXPERIENCED IMPLANT-RELATED IRRITATION AFTER RIB FIXATION. MANY OF THE PATIENTS CONSIDERING IMPLANT REMOVAL. (N=2.2%) PATIENTS UNDERWENT IMPLANT REMOVAL. (N=1.4%) HAD SYMPTOMATIC NON-UNION. (N=26.4%) PATIENTS APPEARED TO DEVELOP PNEUMONIA MORE FREQUENTLY AFTER RIB FIXATION. (N=4.4%) PATIENTS WHO UNDERWENT RIB FIXATION DEVELOPED PLEURAL EFFUSION. (N=8.1 %) PATIENTS WHO UNDERWENT RIB FIXATION DEVELOPED PNEUMOTHORAX DURING THEIR HOSPITAL STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2249921 UNK - CONSTRUCTS: MATRIXRIB PLATE/SCREWS PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention