BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: MATRIXRIB PLATE/SCREWS

    MDR report key: 23555871 · Received November 14, 2025

    Report

    Report Number
    8030965-2025-11431
    Event Type
    Injury
    Date Received
    November 14, 2025
    Date of Event
    January 24, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. H11 ADDITIONAL NARRATIVE: H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. INVESTIGATION SUMMARY. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL MANUFACTURER NARRATIVE: 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: PEUKER F, HAVEMAN RA, HOUWERT RM, BOSCH TP, HOEPELMAN RJ, MINERVINI F, BEERES FJP, VAN DE WALL BJM; NEXT STUDY GROUP. IMPLANT IRRITATION AND REMOVAL RATES IN OPERATIVELY TREATED MULTIPLE RIB FRACTURES: A 49-MONTH FOLLOW-UP STUDY. EUR J TRAUMA EMERG SURG. 2025 JAN 24;51(1):76. DOI: 10.1007/S00068-024-02681-X. PMID: 39856437; PMCID: PMC11761822. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS PROSPECTIVE STUDY WAS TO EXAMINE HOW DIFFERENT SURGICAL METHODS AFFECT LONG-TERM OUTCOMES. THE PRESENT STUDY ALSO TO PROVIDE LONG-TERM INSIGHTS INTO THE RATES OF IMPLANT IRRITATION, SUBSEQUENT REMOVAL, AND REMISSION IN PATIENTS WITH MULTIPLE RIB FRACTURES USING DATA FROM A LARGE INTERNATIONAL PROSPECTIVE STUDY (OPVENT BETWEEN JANUARY 2018 AND MARCH 2021, A TOTAL OF 83 PATIENTS WERE INCLUDED IN THE STUDY, SUBDIVIDED INTO TWO GROUPS: FLAIL (N=30) PATIENTS. CONSISTS OF 23 MALES. THE MEAN AGE OF 61.4 (15.9). WHILE THE NON-FLAIL RIB FRACTURED PATIENTS (N=53). WITH 42 MALES WITH THE MEAN AGE OF 62.3 (13.2). DEPUY SYNTHES (MATRIXRIBTM FIXATION SYSTEM) WAS USED FOR RIB FIXATIONS. MEDIAN FOLLOW-UP PERIOD 49 MONTHS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SYNTHES MATRIXRIB FIXATION SYSTEM. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: MATRIXRIB PLATE/SCREWS (QTY 56). PRIMARY OUTCOME: FOUR PATIENTS UNDERWENT IMPLANT REMOVAL DUE TO IMPLANT IRRITATION; INTERVENTION: IMPLANT REMOVAL FOR IRRITATION WAS PERFORMED AFTER A MEDIAN INTERVAL OF 29 MONTHS (RANGE 28¿47 MONTHS) AFTER FIXATION. SECONDARY OUTCOMES: AT FOLLOW-UP, TWENTY-FIVE PATIENTS EXPERIENCED IMPLANT IRRITATION: NO INTERVENTION PROVIDED. SEVEN PATIENTS CONSIDERED IMPLANT REMOVAL: NO INTERVENTION PROVIDED. EIGHT PATIENTS DEEMED THE OPERATION UNNECESSARY: NO INTERVENTION PROVIDED. SIX PATIENTS CITED FEAR AS THE REASON FOR NOT PURSUING THE PROCEDURE: NO INTERVENTION PROVIDED. ONE REPORTED NO IMPROVEMENT OR DETERIORATION OF SYMPTOMS AFTER REMOVAL: NO INTERVENTION PROVIDED. ADDITIONALLY, TWO MORE PATIENTS REQUIRED IMPLANT REMOVAL WITHIN THE FIRST YEAR DUE TO IMPLANT FAIL: NO INTERVENTION PROVIDED. ONE PATIENT CLAIMED TO HAVE UNDERGONE IMPLANT REMOVAL AT ONE OF THE ADMITTING HOSPITALS: NO INTERVENTION PROVIDED. ONE PATIENT EXHIBITED A SUPERFICIAL SKIN INFECTION AT THE IMPLANT SITE AT THE FINAL FOLLOW-UP: NO INTERVENTION PROVIDED. ANOTHER PATIENT EXPERIENCED A DEEP INFECTION SUBSEQUENT TO IMPLANT REMOVAL: NO INTERVENTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2562022 UNK - CONSTRUCTS: MATRIXRIB PLATE/SCREWS PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention