BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: MATRIXRIB PLATE/SCREWS

    MDR report key: 12501770 · Received September 20, 2021

    Report

    Report Number
    8030965-2021-07887
    Event Type
    Injury
    Date Received
    September 20, 2021
    Report Date
    August 23, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN MATRIXRIB SYSTEM/ UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. 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 · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: SEDAGHAT, N, ET AL. (2021), EARLY OUTCOMES OF SURGICAL STABILISATION OF TRAUMATIC RIB FRACTURES: SINGLE-CENTER REVIEW WITH A REAL-WORLD EVIDENCE PERSPECTIVE, JOURNAL OF SURGICAL RESEARCH, VOLUME 264, PAGES 222-229, (AUSTRALIA). THE AIM OF THIS STUDY WAS TO INVESTIGATE THE OUTCOMES OF EARLY EXPERIENCE WITH SURGICAL STABILIZATION OF RIB FRACTURES. THE SECONDARY AIM OF THIS STUDY WAS TO INVESTIGATE THE PREOPERATIVE CHARACTERISTICS, INCLUDING INDICATIONS FOR SURGICAL STABILIZATION OF RIB FRACTURES AS WELL AS INJURY PROFILE AND TIME TO OPERATION. BETWEEN JANUARY 2013 TO DECEMBER 2018, 63 PATIENTS WHO UNDERWENT SURGICAL STABILIZATION OF RIB FRACTURES WERE INCLUDED IN THE STUDY. THE MEAN AGE WAS 55.9 +/-14.1 YEARS AND 55 PATIENTS WERE MALES. SURGICAL STABILIZATION OF RIB FRACTURES WAS COMPLETED USING ONE OF 2 SYSTEMS: THE UNKNOWN SYNTHES MATRIXRIB SYSTEM AND A COMPETITOR¿S PLATE FIXATION SYSTEM. AT THE CONCLUSION OF THE PROCEDURE, A CHEST TUBE IS PLACED THROUGH THE THORACOSCOPIC PORT SITE. THE CHEST TUBE WAS RE- MOVED WHEN THERE WAS NO EVIDENCE OF CONTINUING AIR LEAK AND MINIMAL DRAIN OUTPUT (LESS THAN 200 ML/24 HOUR). THE ARTICLE DID NOT SPECIFY WHICH PATIENTS RECEIVED THE SYNTHES OR THE COMPETITOR¿S DEVICE. THUS, COMPLICATIONS WILL BE REPORTED AS FOLLOWS: 4 PATIENTS HAD WOUND INFECTION REQUIRING ORAL ANTIBIOTICS. 2 PATIENTS HAD EMPYEMA REQUIRING DECORTICATION. 1 PATIENT HAD CHEST WALL HEMATOMA MANAGED NON-OPERATIVELY. 1 PATIENT HAD CARDIAC TAMPONADE REQUIRING A PERICARDIAL WINDOW. THIS WAS AN INTRAOPERATIVE COMPLICATION INVOLVING AN EPICARDIAL LACERATION TO THE LEFT VENTRICLE DURING THE OPEN REDUCTION INTERNAL FIXATION. THIS REQUIRED FORMATION OF PERICARDIAL WINDOW INTRAOPERATIVELY, WITHOUT ANY FURTHER POSTOPERATIVE COMPLICATIONS. 12 PATIENTS HAD PNEUMONIA. 9 PATIENTS HAD VENOUS THROMBOEMBOLISM. 1 PATIENT DIED SECONDARY TO PALLIATION DUE TO SIGNIFICANT MULTI-SYSTEM ORGAN FAILURE, UNRELATED TO SURGICAL STABILIZATION OF RIB FRACTURES. THIS REPORT IS FOR THE UNKNOWN SYNTHES MATRIXRIB SYSTEM. THIS REPORT CAPTURES THE REPORTED EVENTS OF WOUND INFECTION. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1399886 UNK - CONSTRUCTS: MATRIXRIB PLATE/SCREWS PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention