BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 15055773 · Received July 19, 2022

    Report

    Report Number
    2210968-2022-05651
    Event Type
    Injury
    Date Received
    July 19, 2022
    Date of Event
    February 6, 2021
    Report Date
    July 19, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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? 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. 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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2022-05652. CITATION: JOURNAL OF CRANIO-MAXILLO-FACIAL SURGERY (2021);49:1026-1034. HTTPS://DOI.ORG/10.1016/J.JCMS.2021.01.026.

    Description of Event or Problem · 0

    TITLE: COMPARISON BETWEEN 3D DELTA PLATE AND CONVENTIONAL MINIPLATE IN TREATMENT OF CONDYLAR FRACTURE: A RANDOMISED CLINICAL TRIAL THE AIM OF THIS STUDY WAS TO CONDUCT A RANDOMIZED CLINICAL TRIAL COMPARING THE EFFICACY OF STANDARD NON-COMPRESSION MINIPLATE AND 3-DIMENSIONAL (3D) TITANIUM PLATE IN THE OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE MANDIBULAR CONDYLAR FRACTURES. A TOTAL OF 20 PATIENTS (18 MALE AND 2 FEMALE) WHO UNDERWENT OPEN REDUCTION OF MANDIBULAR CONDYLAR FRACTURE FROM 2016 TO 2019 WERE INCLUDED. TEN PATIENTS WERE RANDOMIZED IN EACH GROUP: GROUP A COMPRISED PATIENTS TREATED USING CONVENTIONAL MINIPLATES, AND GROUP B COMPRISED PATIENTS TREATED USING 3D DELTA PLATE. LAYERWISE SUTURING WAS PERFORMED USING 5-0 VICRYL SUTURES AND 3-0 PROLENE/SILK FOR CLOSURE OF THE SURGICAL SITE. SUTURES WERE REMOVED ON THE POST-OPERATIVE DAY 7. REPORTED COMPLICATIONS INCLUDE PAIN OF 3-5 WHICH LASTED FOR 1 WEEK (N=20) WHICH WAS MANAGED WITH ORAL ANALGESICS IN GROUP A PATIENTS; AND WOUND DEHISCENCE (N=2) WHICH WAS MANAGED EFFICIENTLY BY JUDICIOUS USE OF ANTIBIOTICS AND WOUNDS WERE FREE OF ANY SIGNS OF INFECTIONS OR DISCHARGE IN THE CONSECUTIVE FOLLOW-UPS. IN CONCLUSION, PATIENTS TREATED WITH 3D DELTA PLATES HAVE SUPERIOR OUTCOME WITH REGARD TO OPERATION TIME, MOUTH OPENING, AND BITING EFFICIENCY COMPARED WITH MINIPLATES. HENCE, IT CAN BE CONCLUDED THAT THE TRIANGULAR SHAPE OF THE 3D DELTA PLATE ALLOWS THE STRESS DISTRIBUTION TO BE SUPERIOR AND MULTIDIMENSIONAL, LEADING TO BETTER POST-OPERATIVE STABILITY, FASTER HEALING, AND REDUCED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313422 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention