BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3DMAX

    MDR report key: 23093149 · Received September 19, 2025

    Report

    Report Number
    1213643-2025-00872
    Event Type
    Injury
    Date Received
    September 19, 2025
    Date of Event
    August 1, 2019
    Report Date
    September 8, 2025
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    FTL
    PMA / PMN Number
    K081010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INFORMATION OBTAINED IS LIMITED TO THE CONTENT OF THE ARTICLE. THE PURPOSE OF THE STUDY WAS TO COMPARE METHODS OF IMPLANT FIXATION. FASTENERS VS ADHESIVES. THE FIXATION DEVICES USED IN THE STUDY WERE NOT BARD/DAVOL FIXATION DEVICE. IT CANNOT BE DETERMINED TO WHAT DEGREE, IF ANY, THE USE OF THE BD/BARD MESH TO TREAT THE PATIENT CONTRIBUTED TO THE ADVERSE OUTCOMES REPORTED IN THE ARTICLE. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. HERNIA RECURRENCE IS A CLINICALLY UNDERSTOOD POTENTIAL COMPLICATIONS OF SURGERY/USE OF THE DEVICE AND IS IDENTIFIED IN THE INSTRUCTIONS-FOR-USE PROVIDED WITH THE DEVICE, AS POSSIBLE COMPLICATIONS. NOTE, THE DATE OF EVENT (01-AUG-2019) IS CONSIDERED TO BE A BEST ESTIMATE. THIS MDR REPRESENTS THE 3DMAX MESH. AN ADDITIONAL MDR WAS SUBMITTED TO REPRESENT THE 3DMAX LIGHT MESH. NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    PER JOURNAL ARTICLE: "N-BUTYL-2-CYANOACRYLATE ADHESIVE VERSUS ABSORBABLE TACKS IN LAPAROSCOPIC GROIN HERNIA REPAIR: A MULTICENTER RANDOMIZED CLINICAL TRIAL" BETWEEN AUGUST 2019 AND DECEMBER 2021, 329 PATIENTS WERE ENROLLED AND 284 WERE RANDOMIZED TO NB2C ADHESIVE OR NON-BARD/BD ABSORBABLE TACK FIXATION DEVICE. PATIENTS WHO HAD EITHER A PRIMARY OR RECURRENT UNILATERAL OR BILATERAL INGUINAL OR FEMORAL HERNIA AMENABLE TO A LAPAROSCOPIC TAP OR TOTALLY EXTRAPERITONEAL (TEP) GROIN HERNIA REPAIR WITH A POROUS MESH (LESS THAN OR EQUALS 4X6 IN: 3DMAX, 3DMAX LIGHT). 3DMAX MESH WAS PLACED IN 158 PATIENTS IN NB2C GROUP AND 167 PATIENTS IN ABSORBABLE TACKS GROUP. 3DMAX LIGHT MESH WAS PLACED IN 6 PATIENTS IN NB2C GROUP AND 2 PATIENTS IN ABSORBABLE TACKS GROUP. DROPS OF ADHESIVE ANCHORS WERE SERIALLY DEPLOYED ON THE MESH/TISSUE INTERFACE, WHICH WAS HELD IN PLACE FOR 10 SECONDS FOLLOWING DEPOSITION. POSTOPERATIVE OUTCOMES INCLUDED HERNIA RECURRENCE ONE IN THE NB2C ADHESIVE ARM AND 2 IN THE ABSORBABLE TACK ARM, ONE PATIENT HAD A RECURRENCE AT 3 MONTHS REQUIRING REOPERATION TO REPAIR IT. 1 CASE OF ILIOINGUINAL NEURALGIA THAT BEGAN 6 MONTHS AFTER SURGERY AND REQUIRED AN OUTPATIENT NERVE BLOCK ALONG WITH MEDICAL THERAPY AND A SEPARATE PATIENT WITH ILIOHYPOGASTRIC NEURALGIA REQUIRING 2 INPATIENT ADMISSIONS FOR MEDICAL PAIN CONTROL. NEXT, THERE WAS 1 INCIDENT OF BOWEL OBSTRUCTION WHERE A LOOP OF JEJUNUM WAS ADHERENT TO THE CECUM AND REQUIRED LAPAROSCOPIC ADHESIOLYSIS. ANOTHER PATIENT PRESENTED 3 MONTHS AFTER REPAIR WITH A PURULENT FLUID COLLECTION ADJACENT TO THE MESH REQUIRING IR DRAINAGE. NOTABLY, ALL EVENTS WERE DEEMED ¿POSSIBLY RELATED¿ TO THE DEVICE. ADDENDUM: THE PURPOSE OF THE STUDY WAS TO COMPARE METHODS OF IMPLANT FIXATION. FASTENERS VS ADHESIVES. THE FIXATION DEVICES USED IN THE STUDY WERE NOT BARD/DAVOL FIXATION DEVICE. IT CANNOT BE DETERMINED TO WHAT DEGREE, IF ANY, THE USE OF THE BD/BARD MESH TO TREAT THE PATIENT CONTRIBUTED TO THE ADVERSE OUTCOMES REPORTED IN THE ARTICLE. NOTE: THERE IS NO INFORMATION PROVIDED IN THE ARTICLE INDICATING THAT THE BD/BARD DEVICES CAUSED OR CONTRIBUTED TO THE POSTOPERATIVE PATIENT COMPLICATION(S). HOWEVER, AS POSTOPERATIVE COMPLICATIONS DID PRESENT AND MAY REQUIRE MEDICAL/SURGICAL INTERVENTION WE ARE REPORTING THIS AS A SERIOUS INJURY MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269387 3DMAX SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention