BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VCL CT BRD VIO 36IN 1 S/A CTX

    MDR report key: 21475370 · Received February 26, 2025

    Report

    Report Number
    2210968-2025-02100
    Event Type
    Injury
    Date Received
    February 26, 2025
    Date of Event
    January 7, 2025
    Report Date
    February 26, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? --> YES, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? --> YES, WAS DEVICE EXPLANTED? --> FALSE, DID PATIENT REQUIRE REVISION SURGERY? --> TRUE, IF YES, DATE OF REVISION SURGERY. --> (B)(6) 2025, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> YES 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. PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. DATE OF INDEX SURGICAL PROCEDURE? THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? WHAT WAS THE INITIAL APPROACH FOR THE INDEX SURGICAL PROCEDURE? (OPEN, LAPAROSCOPIC OR OTHER)? ON WHAT TISSUE WAS THE SUTURE USED? WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? PLEASE DESCRIBE ANY MEDICAL/SURGICAL INTERVENTION REQUIRED FOR THIS SUTURE EVENT INCLUDING DATES AND RESULTS. DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? PLEASE DESCRIBE THE PATIENT MANIFESTATIONS OF THE REPORTED REACTION (LOCATION, SEVERITY, APPEARANCE, SYSTEMIC OR LOCAL REACTION). PLEASE PROVIDE THE ONSET DATE/TIME OF THE REACTION FROM THE INITIAL PROCEDURE. OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS? LOT NUMBER? WERE ANY PRE-OP CLEANSING PROCEDURES OR PRODUCTS CHANGED RECENTLY? IF YES, PLEASE DESCRIBE. DOES THE PATIENT HAVE A KNOWN ALLERGIC HISTORY TO ANY MEDICAL DEVICES, FOOD AND/OR MEDICATION? WAS ALLERGY TESTING PERFORMED? IF SO, PLEASE DESCRIBE WITH RESULTS. PLEASE PROVIDE THE RESULTS OF THE CULTURE. ARE THERE ANY PHOTOS AVAILABLE?

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE ARTHRODESIS PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT HAD A REACTION. SURGERY PERFORMED AND SUTURE REMOVED, NEEDED TO REAPPROACH THE PATIENT TO REMOVE THE POINTS, WE COLLECTED CULTURE, WILL REMAIN HOSPITALIZED FOR AN INDEFINITE TIME FOR FOLLOW-UP AND DRESSINGS, AND WE WILL START ANTIBIOTIC. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540562 VCL CT BRD VIO 36IN 1 S/A CTX SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention