3DMAX 0115321Recalls & reported problems

Summary

The FDA's MAUDE database contains 260 adverse event reports that list this exact device (DI 00801741030765), received between Apr 13, 2017 and Sep 25, 2026 — classified as 237 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Defective Device” (166 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 260 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Patient-Device Incompatibility

  Patient problems: Pain

  MAUDE report 50902834 ↗
• InjurySep 23, 2026Patient-Device Incompatibility

  Patient problems: Adhesion(s); Unspecified Infection

  MAUDE report 50873065 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Adhesion(s); Hernia

  MAUDE report 50620008 ↗
• InjurySep 3, 2026Patient-Device Incompatibility

  Patient problems: Discomfort; Pain

  MAUDE report 50593013 ↗
• InjuryAug 12, 2026Patient-Device Incompatibility

  Per information provided:(b)(6) 2014- Patient was diagnosed with recurrent left inguinal hernia, right inguinal hernia, recurrent ventral hernia, thereby underwent robotic assisted laparoscopic repair with implant of Ventralight ST Using Echo PS (Device 1). Per op notes, "The previously placed synthetic mesh was noted on the anterior abdominal wall. Bilateral inguinal hernias were identified. The hernia sac was identified and dissected. A large 3DMax Mesh (Device 1) was then placed in the preperitoneal space in left inguinal region and was sutured. A large 3DMax Mesh (Device 2) was then placed into preperitoneal space in right inguinal region and was sutured. A hernia defect in the midline of the anterior abdominal wall was identified, and a Ventralight ST Using Echo PS (Device 3) was placed in the abdominal region and was sutured."(b)(6) 2017- Patient was diagnosed with recurrent small bowel obstruction, recurrent ventral hernia, thereby underwent open repair with explant of Ventralight ST Using Echo PS (Device 3), implant of synthetic mesh. Per op notes, "An old midline scar was removed. The previous ventral hernia mesh (Device 3) was encountered and excised. Adhesiolysis was per

  Patient problems: Hernia; Obstruction/Occlusion

  MAUDE report 50226234 ↗
• MalfunctionJun 5, 2026Device Contamination with Chemical or Other Material

  AS REPORTED ON (B)(6) 2026, "PRIOR TO OPENING, A BLACK FOREIGN OBJECT WAS OBSERVED ADHERING TO THE MESH." THE PROCEDURE WAS COMPLETED USING ANOTHER MESH. REPORTEDLY, THE OUTER PACKAGING WAS INTACT, AND THE INNER PACKAGING WAS PROPERLY SEALED BEFORE OPENING. AS REPORTED THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25414531 ↗
• InjuryMay 27, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2019: PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST W/ ECHO 2 MESH (DEVICE 1). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE IN THE LEFT UPPER QUADRANT. THE UMBILICAL HERNIA SAC WAS DISSECTED OUT. A VENTRALIGHT ST W/ ECHO 2 MESH (DEVICE 1) WAS PLACED INTO THE ABDOMINAL WALL AND SECURED IT WITH SUTURES.¿ (B)(6) 2020: PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX MESH (DEVICE 2 ¿ RIGHT AND DEVICE 2 ¿ LEFT). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE INTO THE PREPERITONEAL SPACE INFRAUMBILICAL MIDLINE. BOTH INGUINAL HERNIA SACS WERE DISSECTED OUT. TWO 3DMAX MESH (DEVICE 2 ¿ RIGHT AND DEVICE 2 ¿ LEFT) WAS PLACED INTO THE RIGHT AND LEFT INGUINAL FLOOR AND SECURED IT WITH SUTURES.¿ (B)(6) 2021: PATIENT WAS DIAGNOSED WITH CHRONIC GROIN PAIN, RIGHT AND LEFT ILIOINGUINAL NERVE BLOCK, ADHESION, THEREBY UNDERWENT REVISION SURGERY. PER OPERATIVE NOTES, ¿AN INCISION WAS MADE IN THE LEFT UPPER QUADRANT OF THE ABDOMEN. THERE WERE EXTENSIVE ADHESIONS OF OMENTUM AND SMALL BOWELS TO THE ANTERIOR ABDOMINAL WALL TO THE P

  Patient problems: Adhesion(s); Nerve Damage; Pain

  MAUDE report 25304291 ↗
• InjuryMay 21, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH BILATERAL PANTALOONS HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX MESH (DEVICE 1 AND 2). PER OP NOTES, "THE LEFT THEN THE RIGHT LOWER QUADRANTS PERITONEUM WERE DIVIDED. ADHESIONS FROM INCARCERATED LEFT/SIGMOID COLON WAS NOTED. A 3DMAX MESH (DEVICE 1) WAS PLACED ON THE LEFT GROIN AND SECURED TO THE FASCIA WITH SUTURES. A 3DMAX MESH (DEVICE 2) WAS PLACED ON THE RIGHT GROIN AND SECURED TO THE FASCIA WITH SUTURES. ALL THREE DEFECTS THE DIRECT, INDIRECT AND FEMORAL DEFECTS WERE COVERED." ON (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH BILATERAL RECURRENT INGUINAL HERNIAS AND ADHESIONS BETWEEN BOTH OLD MESHES AND CORDS THEREBY UNDERWENT ROBOTIC LAPAROSCOPIC ASSISTED REPAIR WITH IMPLANT OF 3DMAX MESH (DEVICE 3 AND 4). PER OP NOTES, "THE LEFT THEN THE RIGHT LOWER QUADRANTS PERITONEUM WERE DIVIDED. ADHESIONS FROM PREVIOUS BILATERAL INGUINAL HERNIORRHAPHY WAS NOTED. EXTENSIVE LYSIS OF ADHESIONS BETWEEN THE OLD MESHES (DEVICE 1 AND 2) AND THE CORDS BILATERALLY WAS PERFORMED. A 3DMAX MESH (DEVICE 3) WAS PLACED ON THE LEFT GROIN AND SECURED TO THE FASCIA WITH SUTURES. A 3DMAX MESH (DEVICE 4) WAS PLACED ON TH

  Patient problems: Adhesion(s); Hernia

  MAUDE report 25241474 ↗
• MalfunctionApr 15, 2026Device Contamination with Chemical or Other Material

  AS REPORTED, DURING AN INGUINAL HERNIA REPAIR PROCEDURE, PRIOR TO OPENING THE 3DMAX MESH, IT WAS OBSERVED THAT A "SMALL HUMAN HAIR" WAS ENCASED IN THE STERILE PACKAGING. THE PROCEDURE WAS COMPLETED USING ANOTHER MESH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24883830 ↗
• InjuryApr 3, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH BILATERAL RECURRENT INGUINAL HERNIAS THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX MESH (DEVICE 1 AND 2). PER OP NOTES, ¿AN INCISION WAS MADE ABOVE THE UMBILICUS REGION. A BILATERAL INDIRECT RECURRENT INGUINAL HERNIAS WERE IDENTIFIED. MESH WAS NOTED TO BE IN THE RIGHT SIDE FROM PREVIOUS REPAIR. BOTH DEFECTS WERE COMPLETELY DISSECTED FREE. THE 3DMAX MESH (DEVICE 1 AND 2) WERE PLACED INTO BOTH SIDES AND SECURED TOGETHER AT THE MIDLINE WITH SUTURES.¿ (NOTE: THE PRIOR MESH VISUALIZED DURING THIS PROCEDURE WAS UNKNOWN) ATTORNEY ALLEGES HERNIA RECURRENCE, PAIN AND SUFFERING.

  Patient problems: Hernia; Pain

  MAUDE report 24775208 ↗
• InjuryMar 17, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2009 - PATIENT UNDERWENT REPAIR WITH IMPLANT OF 3DMAX MESH (DEVICE 1). (NOTE: THERE IS NO OPERATIVE NOTES PROVIDED FOR THIS PROCEDURE IN PLAINTIFF PROFILE FORM AND MEDICAL RECORDS). ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED REPAIR WITH IMPLANT OF 3DMAX MESH (DEVICE 2). PER OP NOTES, ¿A VERTICAL INCISION WAS MADE. ADHESIONS WERE NOTED IN THE INTRAABDOMINAL SPACE, AND IT WAS DISSECTED AND LYSED. A HERNIA CONTAINING CECUM AND APPENDIX WAS IDENTIFIED IN THE RIGHT INGUINAL CANAL AND THIS WAS INCARCERATED IN THE HERNIA DEFECT. THE HERNIA SAC WAS TAKEN DOWN. THE BLADDER WAS DENSELY ADHERED TO THE ANTERIOR ABDOMINAL WALL AND TAKEN DOWN. THE HERNIA SAC WAS TAKEN OUT OF THE RIGHT INGUINAL AND COMPLETELY REDUCED. A PIECE OF 3DMAX MESH (DEVICE 2) WAS PLACED IN THE RIGHT INGUINAL CANAL AND COVERED BOTH THE DIRECT, INDIRECT AND FEMORAL HERNIA DEFECT SPACES, AND SECURED WITH SUTURES.¿ ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD MESH PRE-SHAPED WITH KEYHOLE (DEVICE 3). PER OP NOTES, ¿AN OBLIQUE INCISION WAS MADE BETWEEN TH

  Patient problems: Hernia; Nerve Damage; Pain

  MAUDE report 24615616 ↗
• InjuryMar 12, 2026Patient-Device Incompatibility

  AS PER ANSM (N° R2606192): PATIENT WAS IMPLANTED WITH A 3DMAX MESH ON (B)(6) 2024. DATE OF OCCURRENCE: 19-SEP-2024. DESCRIPTION OF INCIDENT: PERIOD OF OCCURRENCE SINCE (B)(6) 2024. PAIN SINCE PROSTHESIS INSERTION FOLLOWING RIGHT INGUINAL HERNIA OPERATION. CURRENT PATIENT STATUS: INCREASING PAIN DESPITE CONSULTATIONS WITH SEVERAL DOCTORS. NEUROLOGISTS DO NOT BELIEVE MY PAIN. PAIN COMES AND GOES BUT RETURNS IN A STRANGE WAY, BECOMING MORE AND MORE DIFFUSE AS TIME GOES ON. ACTIONS TAKEN IN THE HEALTHCARE FACILITY TO MANAGE THE PATIENT: NR.

  Patient problems: Pain

  MAUDE report 24582445 ↗
• InjuryMar 5, 2026Patient-Device Incompatibility

  AS REPORTED PER ANSM REPORT: (B)(4). AS REPORTED, PATIENT UNDERWENT LAPAROSCOPIC REPAIR OF RIGHT INGUINAL HERNIA REPAIR ON (B)(6) 2023 DURING WHICH A 3DMAX MESH WAS IMPLANTED. DESCRIPTION OF THE INCIDENT: FOLLOWING THE PROCEDURE ON (B)(6) 2023, THE POST-OPERATIVE PAIN SEEMED NORMAL FOR THIS TYPE OF SURGERY. THE PAIN WAS QUITE SEVERE; I COULD NOT BEAR TO SIT OR STAND, AND I HAD TO REMAIN LYING DOWN. MY WALKING RANGE WAS VERY LIMITED, AND THE 15 MINUTES ALLOWED WERE IMPOSSIBLE TO ACHIEVE. I BEGAN TO EXPERIENCE A BURNING SENSATION IN THE PERINEAL REGION AND PAIN RADIATING TO MY LOWER ABDOMEN AND ENTIRE RIGHT THIGH. AFTER THE FOLLOW-UP CONSULTATION, I WAS TREATED WITH ANTI-INFLAMMATORIES, BUT AS MY PAIN WAS STILL PRESENT AND DEBILITATING, I WAS PUT ON LYRICA AND TOLD TO BE PATIENT, AS VARIOUS ULTRASOUND AND MRI SCANS HAD NOT REVEALED ANYTHING ABNORMAL. I WAS OFF WORK FOR SEVERAL MONTHS BECAUSE I AM A PHYSIOTHERAPIST AND I WAS UNABLE TO RESUME MY WORK. AFTER THREE MONTHS, DESPITE THE PAIN, I RETURNED TO WORK WITH A LIMP AND NOT WITHOUT DIFFICULTY. I TOLD MYSELF THAT I NEEDED MORE TIME OR THAT PERHAPS A NERVE HAD BEEN DAMAGED DURING THE OPERATION. THE PAIN FADED OVER TIME, OR I GOT USED

  Patient problems: Ambulation or Postural Difficulties; Neuralgia

  MAUDE report 24522873 ↗
• InjuryMar 3, 2026Patient-Device Incompatibility

  AS REPORTED PER ANSM (NO. (B)(4): AS REPORTED, ON (B)(6) 2024 THE PATIENT UNDERWENT A BILATERAL LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE WITH THE IMPLANT OF TWO 3DMAX MESH (LEFT AND RIGHT). THE MESH DEVICES WERE SECURED WITH A NON-BD/BARD FIXATION SYSTEM. DATE OF OCCURRENCE: (B)(6) 2024 DESCRIPTION OF THE INCIDENT: "SEVERE PAIN IN RIGHT TESTICLE, SUPERFICIAL THROMBOSIS OF THE PENIS, LOSS OF SENSATION IN LEFT THIGH SINCE SURGERY". THE IMMEDIATE POSTOPERATIVE PERIOD WAS UNEVENTFUL, WITH A RETURN TO A NORMAL DIET THAT WAS WELL TOLERATED, IN ACCORDANCE WITH THE ENHANCED RECOVERY AFTER SURGERY PROTOCOL. GIVEN THE FAVORABLE OUTCOME, HE WAS AUTHORIZED TO RETURN HOME THE SAME DAY. OCCURRENCE OF AN ADVERSE EVENT DURING THE STAY: NO. CURRENT PATIENT STATUS: NEUROPATHIC PAIN CHRONIC TESTICULAR PAIN ON THE RIGHT SIDE, UNEXPLAINED CHRONIC URINARY TRACT INFECTIONS, CHRONIC BALANITIS LEADING TO CIRCUMCISION. DEPRESSION, CONTINUED PAIN ON THE RIGHT SIDE, LIKE CRAMPS. LOSS OF SENSATION IN THE LEFT THIGH ABOVE THE KNEE, ON ANTIDEPRESSANTS SINCE SEPTEMBER 2025. ACTIONS TAKEN IN THE HEALTHCARE FACILITY FOR THE PATIENT'S CARE: NR THIS REPORT REPRESENTS 3DMAX LARGE RIGHT.

  Patient problems: Abdominal Cramps; Depression; Neuralgia; Pain; Thrombosis/Thrombus; Urinary Tract Infection

  MAUDE report 24498058 ↗
• InjuryMar 3, 2026Patient-Device Incompatibility

  AS REPORTED PER ANSM REPORT (R2604195): AS REPORT, THE PATIENT UNDERWENT IMPLANT OF TWO 3DMAX MESH (LEFT AND RIGHT) DEVICES ON (B)(6) 2021, DURING THE REPAIR OF BILATERAL INGUINAL HERNIAS. DATE OF EVENT - 12-JUN-2021 DESCRIPTION OF THE INCIDENT: PAIN IN THE LOWER ABDOMEN AND THIGHS. COMMENTS: MRI (B)(6) 2021: SMALL FLUID POCKET AROUND THE PROSTHESES. PATIENT'S CURRENT CONDITION : UNBEARABLE PAIN 24 HOURS A DAY. DIFFICULTY WALKING, SLEEPING. ACTIONS TAKEN IN THE HOSPITAL TO MANAGE THE PATIENT: NR THIS REPORT REPRESENTS 3DMAX MESH RIGHT.

  Patient problems: Abdominal Pain; Ambulation or Postural Difficulties; Seroma

  MAUDE report 24496590 ↗
• InjuryFeb 26, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX (DEVICE 1 AND 2). PER OP NOTES, ¿ON THE LEFT SIDE, A DIRECT HERNIA DEFECT WAS NOTED AND REDUCED FROM CORD STRUCTURES. A 3DMAX (DEVICE 1 - LEFT) WAS PLACED AND SUTURED. ON THE RIGHT SIDE, A DIRECT HERNIA DEFECT WAS NOTED AND REDUCED FROM CORD. A 3DMAX (DEVICE 2 - RIGHT) PLACED AND SUTURED.¿ ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINODYNIA THEREBY UNDERWENT ROBOTIC ASSISTED REPAIR WITH REMOVAL OF 3DMAX (DEVICE 1 AND 2). PER OP NOTES, ¿BOTH THE MESHES (DEVICE 1 AND 2) WAS EASILY IDENTIFIED AND CLEARED OFF FROM THE ATTACHMENTS. PRIOR MESHES (DEVICE 1 AND 2) WERE EXCISED ENTIRELY.¿ ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG LIGHT (DEVICE 3). PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND FREED FROM THE CORD STRUCTURES. A PERFIX PLUG LIGHT (DEVICE 3) WAS PLACED AND SECURED USING SUTURES TO PUBIC TUBERCLE, CONJOINED TENDON AND SHELVING EDGE AND COVERED DIRECT AND INDIRECT SPACES.¿

  Patient problems: Pain

  MAUDE report 24456020 ↗
• InjuryFeb 10, 2026Patient-Device Incompatibility

  AS REPORTED BY PATIENT VIA ANSM REPORT (N° R2601107): "I HAD MY FIRST SURGERY ON (B)(6) 2023, FOR A LEFT AND RIGHT INGUINAL HERNIA. A BECTON DICKINSON 3DMAX MESH WAS PLACED ON EACH SIDE OF MY ABDOMEN. FOLLOWING PAIN ON THE RIGHT SIDE, I UNDERWENT A SECOND OPERATION ON (B)(6) 2024. A COUSIN BIOSERV BIOMESH PLATE WAS PLACED, BUT THE PAIN IS STILL PRESENT ON THE RIGHT SIDE. THERE IS ALSO PAIN ON THE LEFT SIDE, BUT IT IS LESS SEVERE." ON (B)(6) 2023, THE PATIENT UNDERWENT BILATERAL INGUINAL HERNIA REPAIR BY LAPAROSCOPIC APPROACH (MHJ) AND IMPLANTED WITH 3DMAX MESH LEFT AND RIGHT. ON (B)(6) 2024, A LICHTENSTEIN BIOMESH A2 PLATE WAS IMPLANTED. CURRENT PATIENT STATUS: NR. ACTIONS TAKEN AT THE HEALTHCARE FACILITY TO TREAT THE PATIENT: NR. THIS REPORT REPRESENTS DEVICE #2 (3DMAX-RIGHT).

  Patient problems: Abdominal Pain

  MAUDE report 24306397 ↗
• InjuryFeb 10, 2026Patient-Device Incompatibility

  AS REPORTED, DURING A LEFT INGUINAL HERNIA REPAIR PROCEDURE A 3DMAX MESH WAS IMPLANTED ON (B)(6) 2025. POST IMPLANT THE PATIENT EXPERIENCED CHRONIC PELVIC/GROIN PAIN WITH MOBILITY LIMITATIONS. IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH PELVIC NERVE BLOCK INJECTIONS AND ONE HIP/BUTTOCKS STEROID INJECTION.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 24304569 ↗
• InjuryFeb 3, 2026Patient-Device Incompatibility

  AS PER ANSM REPORT ((B)(4)): DESCRIPTION OF THE INCIDENT: "SINCE THESE IMPLANTS WERE FITTED, AND DESPITE NUMEROUS REPORTS TO MY GP AND THE SURGEON WHO FITTED THE IMPLANTS (3DMAX MESH LEFT- DEVICE1 / 3DMAX RIGHT- DEVICE 2), I HAVE BEEN SUFFERING FROM NUMEROUS ADVERSE EFFECTS ABDOMINAL AND PELVIC PAIN DURING SEXUAL INTERCOURSE DURING EJACULATION, SOMETIMES INCAPACITATING. PERMANENT DIGESTIVE PROBLEMS SIGNIFICANT PAIN WITH ACUTE ATTACKS EVERY MORNING. PAIN DURING EXERTION, WALKING, DRIVING, SITTING OR BENDING (TYING SHOELACES). SIGNIFICANT AND PAINFUL BLOATING. SEVERE AEROPHAGIA. SEVERE FATIGUE INSOMNIA IRRITABILITY DEVELOPMENT OF FOOD INTOLERANCES, SUCH AS DAIRY PRODUCTS. HALITOSIS DESPITE GOOD DENTAL HYGIENE AND REGULAR CHECK-UPS. FEELING OF A HARD FOREIGN BODY (LIKE A PEBBLE). CURRENT CONDITION OF PATIENT: NR. ACTIONS TAKEN BY THE HEALTHCARE FACILITY TO TREAT THE PATIENT: NR.

  Patient problems: Abdominal Pain; Ambulation or Postural Difficulties; Discomfort; Fatigue; Heartburn/Indigestion; Unspecified Gastrointestinal Problem

  MAUDE report 24247698 ↗
• InjuryJan 29, 2026Patient-Device Incompatibility

  AS REPORTED PER ANSM REPORT (B)(4): DATE OF OCCURRENCE/DATE OF IMPLANT (3DMAX MESH): ON (B)(6) 2020. DESCRIPTION OF THE INCIDENT: "CHRONIC PAIN IN THE RIGHT ILIAC FOSSA, PERSISTENT TO DATE, WHEN CARRYING HEAVY LOADS AND IN CERTAIN POSITIONS AND DURING CERTAIN MOVEMENTS." CURRENT PATIENT STATUS: "CHRONIC PAIN IMPACTING QUALITY OF LIFE AND LIMITING PHYSICAL ACTIVITY, PSYCHOLOGICAL IMPACT OF CHRONIC PAIN". ACTIONS TAKEN IN THE HEALTHCARE FACILITY TO TREAT THE PATIENT: NR.

  Patient problems: Depression; Pain

  MAUDE report 24211280 ↗
• InjuryJan 9, 2026Patient-Device Incompatibility

  PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2010 ¿ PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF 3DMAX MESHES (RIGHT - DEVICE 1, LEFT - DEVICE 2). PER OP NOTES, ¿ON RIGHT EXTRAPERITONEAL SPACE, THE CORD LIPOMA WAS SEPARATED. A 3DMAX MESH (DEVICE 1) WAS PLACED INTO RIGHT EXTRAPERITONEAL SPACE AND ATTACHED TO COOPER LIGAMENT AND RECTUS MUSCLE USING TACKS. ATTENTION TO LEFT EXTRAPERITONEAL SPACE, THE HERNIA SAC WAS REDUCED. A 3DMAX MESH (DEVICE 2) WAS PLACED AND ATTACHED TO COOPER LIGAMENT USING TACKS.¿ ON (B)(6) 2020 ¿ PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED REPAIR WITH THE REMOVAL OF MESHES (DEVICE 1, 2) IMPLANT OF 3DMAX MESHES (DEVICE 3, 4). PER OP NOTES, ¿PATIENT WAS FOUND TO HAVE BILATERAL INGUINAL HERNIAS. THE INDIRECT HERNIA SAC AND DIRECT HERNIA SAC WERE REDUCED ON BOTH SIDES. A LARGE 3DMAX MESHES (DEVICE 3, 4) WERE PLACED INTO RIGHT AND LEFT DEFECT ANCHORED TO COOPER LIGAMENT BILATERALLY USING TACKS.¿

  Patient problems: Hernia

  MAUDE report 24020076 ↗
• InjuryJan 9, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA AND UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC AND OPEN REPAIR WITH IMPLANT OF 3DMAX (DEVICE 1) AND VENTRALEX MESH (DEVICE 2). PER OP NOTES, ¿THE DEFECT IN THE UMBILICUS WAS IDENTIFIED WITH BOWEL. THE BOWEL WAS REDUCED. A VENTRALEX MESH (DEVICE 2) WAS PLACED AND SECURED WITH SUTURES. ON THE RIGHT INGUINAL REGION, THE HERNIA DEFECT WAS IDENTIFIED AND REDUCED. A 3DMAX (DEVICE 1) WAS PLACED AND SECURED WITH SUTURES.¿ (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH RECURRENT UMBILICAL HERNIA WITH PAIN, RECURRENT LEFT INGUINAL HERNIA AND BILATERAL INGUINAL PAIN THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WITH EXCISION OF VENTRALEX MESH (DEVICE 2) AND IMPLANT OF 3DMAX LIGHT (DEVICE 3). PER OP NOTES, ¿OMENTAL ADHESIONS TO PRIOR MESH (DEVICE 2) WERE LYSED. THE EXTRUDING PRIOR MESH (DEVICE 2) WAS EXCISED ENTIRELY. THE RECURRENT DEFECT WAS REPAIRED PRIMARILY WITH SUTURES. ON THE LEFT INGUINAL REGION, AN INDIRECT HERNIA SAC WAS NOTED AND REDUCED SEPARATED FROM THE CORD STRUCTURES. THE ILIOINGUINAL, GENITOFEMORAL AND FEMORAL CUTANEOUS NERVES WERE NOTED AND PORTIONS WERE REMOVED. A 3DMAX LIGHT (DEV

  Patient problems: Nerve Damage; Pain

  MAUDE report 24019072 ↗
• InjuryDec 26, 2025Migration; Migration

  PER INFORMATION PROVIDED: ON (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH BILATERAL RECURRENT INGUINAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX (DEVICE 1 AND 2). PER OP NOTES, ¿THE HERNIA DEFECTS WERE NOTED ON BOTH LEFT AND RIGHT INGUINAL REGION. BOTH THE HERNIAS WERE REDUCED. THE HERNIA SAC WAS FAIRLY ADHERENT TO PRIOR MESH. A 3DMAX (DEVICE 1 - LEFT) WAS PLACED ON LEFT SIDE AND SUTURED. ANOTHER 3DMAX (DEVICE 2 - RIGHT) WAS PLACED ON RIGHT SIDE AND SUTURED.¿ ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH ADENOCARCINOMA OF PROSTATE THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WITH PARTIAL EXCISION OF 3DMAX MESHES (DEVICE 1 AND 2). PER OP NOTES, ¿EXTENSIVE ADHESIONS FROM PREVIOUS REPAIR WERE LYSED. THE MESH (DEVICE 1 AND 2) FROM THE PREVIOUS BILATERAL INGUINAL HERNIA REPAIR WERE MIGRATED BELOW THE SYMPHYSIS AND EXCISE A PORTION OF THE MESH (DEVICE 1 AND 2). PROSTATECTOMY WAS PERFORMED.¿

  Patient problems: Adhesion(s)

  MAUDE report 23896906 ↗
• InjuryDec 26, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2016- PATIENT WAS DIAGNOSED WITH SYMPTOMATIC RECURRENT RIGHT INGUINAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 1). PER OP NOTES, ¿THE HERNIA DEFECT WAS IDENTIFIED IN THE FLOOR OF THE RIGHT INGUINAL REGION. A PERFIX PLUG (DEVICE 1) WAS PLACED INTO THE DEFECT AND SUTURED¿. ON (B)(6) 2017- PATIENT WAS DIAGNOSED WITH RIGHT RECURRENT INGUINAL HERNIA, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX MESH (DEVICE 2), BARD FLAT MESH (DEVICE 3) AND A SYNTHETIC MESH. PER OP NOTES, ¿HERNIA WAS NOTICED ON RIGHT AND LEFT SIDE OF THE INGUINAL REGION. ON THE RIGHT SIDE THERE WAS A LARGE DIRECT INGUINAL HERNIA. A LARGE 3DMAX MESH (DEVICE 2) WAS TRIMMED AND PLACED IN THE RIGHT INGUINAL REGION AND THE SYNTHETIC MESH WAS PLACED OVER THE 3DMAX MESH (DEVICE 2) AND TACKED. AGAIN, A LARGE BARD FLAT MESH (DEVICE 3) WAS PLACED CUSTOMIZED, PLACED AND TACKED TO COOPER¿S LIGAMENT ACROSS THE TOP OF FASCIA.¿. ON (B)(6) 2019- PATIENT WAS DIAGNOSED WITH RIGHT RECURRENT INGUINAL HERNIA WITH PAIN, THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WITH IMPLANT OF SYNTHETIC MESH. PER OP NOTES, ¿A RECURRENT DIRECT DEFECT ON THE RIGHT

  Patient problems: Hernia; Pain

  MAUDE report 23896822 ↗
• InjuryDec 26, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2016- PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX MESHES (DEVICE 1 AND 2). PER OP NOTES, ¿INGUINAL CANAL WEAKNESS AND SOME TEARING WAS NOTED. A 3DMAX MESHES (DEVICE 1 AND 2) WAS PLACED ON THE RIGHT AND LEFT INGUINAL REGION AND SUTURED¿. ON (B)(6) 2017- PATIENT WAS DIAGNOSED WITH BILATERAL MUSCLE INJURY, THEREBY UNDERWENT OPEN REPAIR WITH PARTIAL EXPLANT OF 3DMAX MESHES (DEVICE 1 AND 2). PER OP NOTES, ¿THE ILIOINGUINAL NERVE WAS PRESERVED¿.

  Patient problems: Nerve Damage

  MAUDE report 23895915 ↗