BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 20608602 · Received November 5, 2024

    Report

    Report Number
    2210968-2024-11494
    Event Type
    Injury
    Date Received
    November 5, 2024
    Date of Event
    March 25, 2022
    Report Date
    November 5, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    OTHER

    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (B)(4) IS NOT AVAILABLE. CITATION: INT. J. ORAL MAXILLOFAC. SURG. 2022; 51: 1170¿1179 HTTPS://DOI.ORG/10.1016/J.IJOM.2022.03.004.

    Description of Event or Problem · 0

    TITLE: DICED CARTILAGE FOR DORSAL AUGMENTATION IN RHINOPLASTY: EFFECT ON NASAL PROJECTION AND FRONTAL NASAL WIDTH. THE AIM OF THIS QUANTITATIVE STUDY WAS TO COMPARE THE NASAL WIDTH IN FRONTAL VIEW, DORSAL PROJECTION IN PROFILE VIEW, AND THE CHANGE IN STABILITY OF THE GRAFT OVER TIME, IN ORDER TO IDENTIFY THE BETTER TECHNIQUE WHEN DORSAL AUGMENTATION IS REQUIRED. FROM MAY 2013 TO APRIL 2019, 98 PATIENTS (80 FEMALE, 18 MALE) WHO HAD UNDERGONE DORSAL AUGMENTATION WITH DICED CARTILAGE AND WERE FOLLOWED UP FOR A MEDIAN OF 17 MONTHS (RANGE 3¿47 MONTHS) WERE INCLUDED IN THE STUDY. PATIENTS WERE ASSIGNED TO THREE GROUPS BASED ON THE SURGEON¿S PREFERENCE OF TECHNIQUE FOR DORSAL AUGMENTATION: WITH DICED CARTILAGE WRAPPED IN FASCIA (DCIF), FREE DICED CARTILAGE UNDER FASCIA (DCUF), OR FREE DICED CARTILAGE WITHOUT FASCIA (FDC). DORSAL AUGMENTATION WAS PERFORMED BY DICED CARTILAGE WRAPPED IN FASCIA TECHNIQUE IN 51 PATIENTS. FREE DICED CARTILAGE WITHOUT FASCIA (FDC) WAS USED IN 27 PATIENTS, AND 20 PATIENTS UNDERWENT THE FREE DICED CARTILAGE UNDER FASCIA TECHNIQUE (DCUF). THE TEMPORAL FASCIA WAS THE ONLY FASCIA USED IN THE DICED CARTILAGE WRAPPED IN FASCIA (DCIF) AND FREE DICED CARTILAGE UNDER FASCIA (DCUF) GROUPS. ALL DICED CARTILAGE WAS AUTOGRAFT HARVESTED FROM THE SEPTUM, RIB, OR AURICLE. IN THE DICED CARTILAGE WRAPPED IN FASCIA TECHNIQUE (DCIF), DICED CARTILAGE WAS WRAPPED IN FASCIA, AND A FASCIAL SLEEVE WAS CONSTRUCTED WITH 6¿0 PDS (ETHICON) RUNNING SUTURES. THE TWO ENDINGS WERE SECURED USING THE SAME SUTURE THREAD. REPORTED COMPLICATIONS INCLUDED SIGNIFICANT DICED CARTILAGE WRAPPED IN FASCIA MALPOSITION AFTER 3 MONTHS OF FOLLOW-UP (N=1), AND DORSAL ERYTHEMA AND PAIN IN THE SECOND POSTOPERATIVE WEEK AND WERE DIAGNOSED WITH A GRAFT INFECTION (N=2). IN CONCLUSION, EXPERIENCE FROM THIS STUDY SUGGESTS THAT THE APPLICATION OF FREE DICED CARTILAGE WITHOUT FASCIA PREVENTS SUCH COMPLICATIONS WITHOUT SACRIFICING THE DORSAL AUGMENTATION AND THAT DICED CARTILAGE WRAPPED IN FASCIA IS A BETTER CHOICE FOR MORE SEVERE DEFORMITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1599844 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention