BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS PLATE UNKNOWN PRODUCT

    MDR report key: 18893445 · Received March 13, 2024

    Report

    Report Number
    2210968-2024-02967
    Event Type
    Injury
    Date Received
    March 13, 2024
    Date of Event
    January 1, 2024
    Report Date
    October 30, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    NHB
    PMA / PMN Number
    K092590
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC 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 INFORMATION: THE FULL ARTICLE HAS BEEN RECEIVED. HTTPS://DOI.ORG/10.1055/A-2262-8050.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, 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. AS NO CONTACT INFORMATION HAS BEEN PROVIDED, NO FOLLOW UP CAN OR WILL BE PERFORMED AT THIS TIME. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: J NEUROL SURG B SKULL BASE. 2024.

    Description of Event or Problem · 0

    TITLE: UTILIZATION OF POLYDIOXANONE PLATE FOR ENDOSCOPIC ANTERIOR SKULL BASE REPAIR: OPERATIVE TECHNIQUE AND LONG-TERM COHORT OUTCOMES. THE PURPOSE OF THIS STUDY IS TO REPORT THE TECHNICAL PROCEDURE AND OUR EXPERIENCE USING A POLYDIOXANONE SUTURE PLATE (PDS PLATE, ETHICON) WITH DURAL SUBSTITUTE AS PART OF A FULLY RESORBABLE GASKET SEAL TECHNIQUE TO REPAIR ANTERIOR SKULL BASE DEFECTS. BETWEEN JANUARY 2014 AND JULY 2022, 155 PATIENTS UNDERGOING ANTERIOR SKULL BASE RECONSTRUCTION UTILIZING THE RESORBABLE GASKET SEAL TECHNIQUE WERE INCLUDED IN THE STUDY. REPORTED COMPLICATIONS INCLUDED POSTOPERATIVE CEREBROSPINAL FLUID LEAKS REQUIRING REOPERATION (N=9). IN CONCLUSION, PDS PLATE RECONSTRUCTION CONFERS SEVERAL ADVANTAGES AND CAN BE USED IN A DIVERSE SET OF OPERATIVE SCENARIOS IN CONJUNCTION WITH OTHER RECONSTRUCTION OPTIONS. THERE APPEARED TO BE AN ASSOCIATED LEARNING CURVE AS SURGEONS AT OUR CENTER GAINED EXPERIENCE WITH THIS NEW TECHNIQUE. OUR FINDINGS SHOW THAT THE PDS PLATE RECONSTRUCTION IS SAFE AND EFFECTIVE IN REPAIRING THE SKULL BASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181384 PDS PLATE UNKNOWN PRODUCT POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE NHB ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention