BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: MATRIXRIB

    MDR report key: 12558110 · Received September 30, 2021

    Report

    Report Number
    2939274-2021-05847
    Event Type
    Injury
    Date Received
    September 30, 2021
    Report Date
    September 1, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS FOR AN UNK - SCREWS: MATRIXRIB/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI 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 AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. THE 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. 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: HERNANDEZ M., ET AL (2018) BONE AUTOGRAFT COUPLED WITH LOCKING PLATES REPAIRS SYMPTOMATIC RIB FRACTURE NONUNION, THE AMERICAN SURGEON VOLUME 84, PAGES 844-850 (USA). THIS STUDY AIMS TO EVALUATE OUR EVOLVING EXPERIENCE WITH SURGICAL STABILIZATION OF RIB FRACTURES (SSRFS) COUPLED WITH BONE AUTOGRAFT TO TREAT SYMPTOMATIC RIB FRACTURE NONUNION. DURING 2010 TO 2014, A TOTAL OF SIX PATIENTS WITH A MEAN AGE (± SD) OF 53.5 ± 7.4 YEARS WERE INCLUDED IN THE STUDY. DURING THE STUDY PERIOD, WE USED DIFFERENT SYSTEMS TO INCLUDE THE MATRIXRIB FIXATION SYSTEM (DEPUY SYNTHES, WEST CHESTER, PA), SYNTHES MINI-MODULAR PLATING SYSTEM (DEPUY SYNTHES), AND RIBLOC RIB FRACTURE PLATING SYSTEM (ACUTE INNOVATIONS, HILLSBORO, OR). THE FOLLOWING COMPLICATIONS WERE REPORTED: COMPLICATIONS INCLUDED FROM THE PLATING (A SINGLE SCREW FAILURE AND PLATE FAILURE) REQUIRING REOPERATION. A CASE OF A (B)(6) YEAR-OLD MALE WHO UNDERWENT RIB FIXATION SYSTEM (SYNTHES) HAD PLATE FRACTURE POSTOPERATIVELY. A CASE OF A (B)(6) YEAR-OLD MALE WHO UNDERWENT RIB FIXATION SYSTEM (SYNTHES) HEMATOMA AND PLATE DISPLACED POSTOPERATIVELY. A CASE OF A (B)(6) YEAR-OLD MALE WHO UNDERWENT RIB FIXATION SYSTEM (SYNTHES) HAD SEROMA POSTOPERATIVELY. A CASE OF A (B)(6) YEAR-OLD MALE WHO UNDERWENT RIB FIXATION SYSTEM (SYNTHES) HAD PLATE DISPLACED POSTOPERATIVELY. THIS REPORT IS FOR AN UNKNOWN SYNTHES MATRIXRIB FIXATION SYSTEM, AND SYNTHES MINI-MODULAR PLATING SYSTEM. THIS REPORT IS FOR (1) UNK - SCREWS: MATRIXRIB. THIS REPORT IS 3 OF 12 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1451600 UNK - SCREWS: MATRIXRIB SCREW, FIXATION, BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention