BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: MATRIXRIB PLATE/SCREWS

    MDR report key: 19329530 · Received May 16, 2024

    Report

    Report Number
    8030965-2024-06314
    Event Type
    Injury
    Date Received
    May 16, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    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: D1, D2, D3, D4, G4-510K: THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: MATRIXRIB PLATE/SCREWS/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. E1: STUDY WAS CONDUCTED IN THE NETHERLANDS AND SWITZERLAND. FACILITY NAME AND ADDRESS FOR SWITZERLAND LOCATION: DEPARTMENT OF THORACIC SURGERY, LUZERNER KANTONSSPITAL, LUCERNE, SWITZERLAND. 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: HOEPELMAN RJ ET AL. (2023), QUALITY OF LIFE AND CLINICAL OUTCOMES OF OPERATIVELY TREATED PATIENTS WITH FLAIL CHEST INJURIES: A MULTICENTRE PROSPECTIVE COHORT STUDY, FRONT. SURG. 10:1156489. DOI: 10.3389/FSURG.2023.1156489 (THE NETHERLANDS) THE AIM OF THIS STUDY WAS TO REPORT SHORT AND LONG-TERM OUTCOMES OF A COHORT OF OPERATIVELY TREATED FLAIL CHEST PATIENTS. BETWEEN JANUARY 2018 TO MARCH 2021, 87 PATIENTS WITH CLINICAL FLAIL CHEST INJURIES WERE INCLUDED OF WHOM 61 PATIENTS (43 MALES, MEAN AGE 60.8 ± 15.9 YEARS) WERE TREATED OPERATIVELY. AFTER REDUCTION, IDEALLY INTERNAL FIXATION WAS PERFORMED USING AT LEAST 3 BICORTICAL SCREWS ON EACH SIDE OF THE FRACTURE AND THE UNKNOWN SYNTHES MATRIXRIB SYSTEM. FOLLOW-UP WAS COMPLETED MARCH 2022, WITH A COMPLETION RATE OF 77 PERCENT. COMPLICATIONS WERE REPORTED AS FOLLOWS: 2 PATIENTS HAD IMPLANT-RELATED COMPLICATIONS. REVISIONS WERE PERFORMED. 1 IMPLANT DISLOCATED DURING THE INITIAL IN-PATIENT STAY, WHILE THE SECOND DISLOCATION WAS DETECTED DURING FOLLOW-UP. 2 PATIENTS HAD PNEUMONIA AT 6 WEEKS POSTOPERATIVE. ANTIMICROBIAL THERAPY NEEDED. 2 PATIENTS HAD PLEURAL EFFUSION AT 6 WEEKS POSTOPERATIVE. 15 PATIENTS REPORTED IRRITATION AND 2 PATIENTS HAD THE IMPLANTS REMOVED PRIOR TO THE 1-YEAR FOLLOW-UP. 2 PATIENTS DIED DURING ADMISSION. 1 PATIENT DEVELOPED PNEUMONIA AND DIED DUE TO RESPIRATORY FAILURE. THE SECOND PATIENT DIED DUE TO UNRELATED CAUSES. 1 PATIENT HAD DIED PRIOR TO THE 1-YEAR FOLLOW-UP DUE TO CAUSES UNRELATED TO THE THORACIC TRAUMA. THIS REPORT IS FOR THE UNKNOWN SYNTHES MATRIXRIB SYSTEM. A COPY OF THE CLINICAL EVALUATION FORM IS BEING SUBMITTED WITH THIS REGULATORY REPORT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548700 UNK - CONSTRUCTS: MATRIXRIB PLATE/SCREWS PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention