BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: MATRIXRIB PLATE/SCREWS

    MDR report key: 23586525 · Received November 18, 2025

    Report

    Report Number
    8030965-2025-11559
    Event Type
    Injury
    Date Received
    November 18, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: 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

    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. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, (B)(4) IS NOT AVAILABLE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: EL KAYALI MKD, BÖNING G, MEWES MG, BRAUN KF, STEINECKE K, NEUMANN K, STÖCKLE U, JAECKER V, NIEMANN M. IMPACT OF SURGICAL STABILIZATION OF FLAIL CHEST INJURIES ON POSTOPERATIVE COMPUTED TOMOGRAPHY LUNG VOLUMES. J CLIN MED. 2025 MAY 22;14(11):3644. DOI: 10.3390/JCM14113644. PMID: 40507409; PMCID: PMC12155564. OBJECTIVE/METHODS/STUDY DATA: THIS RETROSPECTIVE STUDY AIMS TO ASSESS EARLY CT-BASED LUNG VOLUME CHANGES IN OPERATIVELY TREATED FC PATIENTS BEFORE AND AFTER SURGERY AND TO COMPARE THE CHANGES IN RESPIRATORY INVASIVENESS AFTER STABILIZATION OF THE FLAIL SEGMENTS. WITH THIS, EARLY POSTOPERATIVE CT SCANS SHALL BE EVALUATED AS A SURROGATE PARAMETER FOR RECONSTRUCTION EFFECTIVENESS. BETWEEN 2011 AND 2024, A TOTAL OF 21 PATIENTS (90.48% MALE) WERE OPERATIVELY TREATED FOR THEIR FC INJURY. THE PATIENTS WERE 49 (IQR 38, 68) YEARS OF AGE, AND MOST (90.48%) WERE MALE. THE MATRIXRIB TM SYSTEM (DEPUY SYNTHES, RAYNHAM, MA, USA) IS THE SOLE SYSTEM USED TO STABILIZE FC INJURIES, AND THE STANDARD SURGICAL TREATMENT CONCEPT EMPLOYED HAS BEEN DESCRIBED BEFORE. THE MEAN DURATION FOLLOW-UP WAS 7 MONTHS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SYNTHES MATRIXRIB TM SYSTEM ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: MATRIXRIB PLATE/SCREWS (QTY 22): 1 PATIENT HAD TRAUMATIC CARDIAC DISLOCATION; TREATED OPERATIVELY ON THE DAY OF HOSPITAL ADMISSION. 2 PATIENTS HAD AORTIC DISSECTION TYPE STANFORD A; TREATED OPERATIVELY ON THE DAY OF HOSPITAL ADMISSION. 1 PATIENT HAD RUPTURED TRUNCUS PULMONALIS; TREATED OPERATIVELY ON THE DAY OF HOSPITAL ADMISSION. 6 PATIENTS HAD THORACIC SPINE INJURIES; NO INTERVENTION WAS NOTED. 5 PATIENTS HAD LUMBAR SPINE INJURY TYPES INCLUDED: A1, A2, B2, B3, AND C FRACTURES; SOME REQUIRED OPEN SURGERY OR PERCUTANEOUS SPINAL FUSION. 6 PATIENTS (28.57%) HAD ASSOCIATED LIMB INJURIES, INCLUDING COMPLEX FRACTURES AND LIGAMENT INJURIES. NO INTERVENTION WAS NOTED. 1 PATIENT REQUIRED REOPERATION AFTER THORAX DRAIN REMOVAL DUE TO RESPIRATORY FAILURE AND RECEIVED A SECONDARY DRAIN DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2325360 UNK - CONSTRUCTS: MATRIXRIB PLATE/SCREWS PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention