BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VICRYL RAPIDE SUTURE

    MDR report key: 13157309 · Received January 4, 2022

    Report

    Report Number
    2210968-2022-00018
    Event Type
    Injury
    Date Received
    January 4, 2022
    Date of Event
    November 5, 2020
    Report Date
    January 4, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. 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. (B)(4). RELATED EVENTS CAPTURED VIA 2210968-2022-00015, 2210968-2022-00016, 2210968-2022-00017, 2210968-2022-00020, 2210968-2022-00022, 2210968-2022-00024, 2210968-2022-00026, 2210968-2022-00028, 2210968-2022-00030, 2210968-2022-00032, 2210968-2022-00034, 2210968-2022-00036, 2210968-2022-00038, 2210968-2022-00040, 2210968-2022-00041, 2210968-2022-00043, 2210968-2022-00045, 2210968-2022-00047 AND 2210968-2022-00048. CITATION: INT. J. ORAL MAXILLOFAC. SURG. 2021; 50: 643¿648 HTTPS://DOI.ORG/10.1016/J.IJOM.2020.09.024

    Description of Event or Problem · 0

    TITLE: ANTIBIOTICS IN ORTHOGNATHIC SURGERY: A RETROSPECTIVE ANALYSIS AND IDENTIFICATION OF RISK FACTORS FOR POSTOPERATIVE INFECTION. THE AIM OF THIS STUDY WAS TO DETERMINE THE INFECTION RATE AT (B)(6)- HOSPITAL, TILBURG, THE NETHERLANDS AND TO COMPARE THIS TO RATES REPORTED IN THE CURRENTLY AVAILABLE LITERATURE. IN ADDITION, POSSIBLE RISK FACTORS FOR INFECTION AND THE REMOVAL OF OSTEOSYNTHESIS MATERIAL WERE IDENTIFIED. A TOTAL OF 137 PATIENTS, 51 (37.2%) MALE AND 86 (62.8%) FEMALE UNDERGOING ORTHOGNATHIC SURGERY (LE FORT I OSTEOTOMY (LFI), BILATERAL SAGITTAL SPLIT OSTEOTOMY (BSSO), AND BIMAXILLARY OSTEOTOMY) AT THE STUDY INSTITUTE BETWEEN AUGUST 1, 2017 AND JULY 31, 2018 WERE INCLUDED. STANDARDIZED LFI OSTEOTOMIES WERE PERFORMED USING A RECIPROCATING SAW. AFTER PTERYGOMAXILLARY DISJUNCTION, DOWN FRACTURE WAS PERFORMED. THE UPPER JAW WAS POSITIONED AND FIXED WITH MINIPLATES (1.5 SYSTEM; KLS MARTIN, TUTTLINGEN, GERMANY). A STANDARD BSSO WAS PER- FORMED USING THE HUNSUCK¿EPKER MODIFICATION14,13. AFTERBILATERALSPLIT, FIXATION WAS PERFORMED USING MINIPLATES (2.0 SYSTEM; KLS MARTIN, TUTTLINGEN, GERMANY). SLIDING GENIOPLASTIES WERE CONDUCTED WITH A RECIP- ROCATING SAW AND FIXED WITH CHIN PLATES (KLS MARTIN, TUTTLINGEN, GERMANY). IF THIRD MOLAR TEETH WERE REMOVED DURING SURGERY, THE NORMAL OSTEOTOMIES WERE COMMENCED. UPON VISUALIZATION OF THE TOOTH, LUXATION AND REMOVAL WAS ACCOMPLISHED. ALL WOUNDS WERE CLOSED WITH RESORBABLE POLYGLACTIN SUTURES (VICRYL RAPIDE 3¿0;(B)(6) USA). DRAINS WERE NEVER USED. NO FOREIGN MATERIAL WAS PLACED IN BETWEEN THE OSTEOTOMY SITES. REPORTED COMPLICATIONS INCLUDED: A (B)(6) FEMALE PATIENT EXPERIENCED POSTOPERATIVE INFECTIONS A (B)(6) FEMALE PATIENT EXPERIENCED POSTOPERATIVE INFECTIONS A (B)(6) FEMALE PATIENT EXPERIENCED POSTOPERATIVE INFECTIONS A (B)(6) FEMALE PATIENT EXPERIENCED POSTOPERATIVE INFECTIONS A (B)(6) FEMALE PATIENT EXPERIENCED POSTOPERATIVE INFECTIONS A (B)(6) FEMALE PATIENT EXPERIENCED POSTOPERATIVE INFECTIONS A (B)(6) MALE PATIENT EXPERIENCED POSTOPERATIVE INFECTIONS A (B)(6) FEMALE PATIENT EXPERIENCED POSTOPERATIVE INFECTIONS A (B)(6) MALE PATIENT EXPERIENCED POSTOPERATIVE INFECTIONS A (B)(6) MALE PATIENT EXPERIENCED POSTOPERATIVE INFECTIONS A (B)(6) MALE PATIENT EXPERIENCED POSTOPERATIVE INFECTIONS A (B)(6) MALE PATIENT EXPERIENCED POSTOPERATIVE INFECTIONS A (B)(6) FEMALE PATIENT EXPERIENCED POSTOPERATIVE INFECTIONS A (B)(6) FEMALE PATIENT EXPERIENCED POSTOPERATIVE INFECTIONS A (B)(6) MALE PATIENT EXPERIENCED POSTOPERATIVE INFECTIONS A (B)(6) MALE PATIENT EXPERIENCED FPOSTOPERATIVE INFECTIONS A (B)(6) FEMALE PATIENT EXPERIENCED POSTOPERATIVE INFECTIONS A (B)(6) FEMALE PATIENT EXPERIENCED POSTOPERATIVE INFECTIONS A (B)(6) PATIENT EXPERIENCED POSTOPERATIVE INFECTIONS A (B)(6) MALE PATIENT EXPERIENCED FPOSTOPERATIVE INFECTIONS IN CONCLUSION, THIS STUDY SHOWED AN INFECTION RATE OF 14.6% WITH NO LINK TO ANY DEMOGRAPHIC RISK FACTOR. NEITHER THE SIMULTANEOUS REMOVAL OF THIRD MOLAR TEETH NOR GENIOPLASTY WAS FOUND TO BE A RISK FACTOR FOR SSI. FOR LITERATURE COMPARISON PURPOSES, THERE IS A CLEAR NEED FOR THE INTERNATIONAL GUIDELINES DEFINING SSI TO BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479333 UNKNOWN VICRYL RAPIDE SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention