3DMAX 0115320Recalls & reported problems

Summary

The FDA's MAUDE database contains 118 adverse event reports that list this exact device (DI 00801741030758), received between Mar 28, 2017 and Sep 3, 2026 — classified as 117 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (88 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 118 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2026Material Deformation

  Per information provided:On (b)(6) 2020 - Patient was diagnosed with bilateral inguinal hernia thereby underwent robotic assisted repair with implant of 3DMax Mesh (Device 1 and 2). Per op notes, "An incision was made. Omental adhesions were taken down. Left peritoneum was taken down and identified both the indirect and direct defect which were reduced from the spermatic cord. A large piece of 3DMax Mesh (Device 1) was placed and the peritoneum was secured with suture. On the right side, the peritoneum was taken down in a similar fashion and a defect was noted in a direct position. A medium piece of 3DMax Mesh (Device 2) was placed and secured the peritoneum with suture."On (b)(6) 2020 - Patient was diagnosed with adhesions to the site of bilateral inguinal hernia thereby underwent robotic assisted repair with partial excision of 3DMax Mesh (Device 2). Per op notes, "Old incision site was used. Extensive adhesions between the omentum and bowel to both inguinal hernia repair sites were noted. Adhesions were taken down. Well incorporated mesh was noted in the left inguinal repair site. The right side had an area of wrinkles in its lateral portion and these were attached to the adhesi

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

  MAUDE report 50584841 ↗
• InjuryAug 26, 2026Patient-Device Incompatibility

  Per information provided:(b)(6)2013 - Patient was diagnosed with right inguinal hernia thereby underwent open repair with implant of PerFix Plug (Device 1). Per op notes, ¿Incision was made in the right groin. The cord contents were reduced. The contents of the hernia sac were reduced. The hernia sac was dissected free. There was a small defect in the ring. A PerFix Plug (Device 1) was placed and sutured. A patch was placed in the floor and sutured.¿ (b)(6)2014 - Patient was diagnosed with recurrent right sided inguinal hernia and left inguinal hernia thereby underwent laparoscopic repair with implant of 3DMax (Device 2 and 3). Per op notes, ¿On the right inguinal region, a recurrent indirect hernia sac was identified and reduced. The old mesh (Device 1) was stuck in the hernia sac was dissected. No evidence of direct or femoral hernia. There was preperitoneal fat in the femoral space was reduced. A 3DMax (Device 2) was placed and tacked to cooper's ligament. On the left inguinal region, an indirect hernia sac was identified and reduced. A 3DMax (Device 3) was placed and tacked to cooper's ligament.¿ (b)(6)2015 ¿ Patient had right lower quadrant pain for six months and right groin

  Patient problems: Pain; Seroma

  MAUDE report 50449031 ↗
• InjuryJun 29, 2026Migration

  PER INFORMATION PROVIDED: ON (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH BILATERAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX MESH (DEVICE 1 - LEFT AND DEVICE 2 - RIGHT). PER OPERATIVE NOTES, "A SMALL INCISION WAS MADE IN THE LOWER ABDOMEN IN THE LEFT INGUINAL REGION. THE LEFT INGUINAL HERNIA SAC WAS DISSECTED OUT. A 3DMAX MESH (DEVICE 1) WAS PLACED INTO THE LEFT INGUINAL FLOOR AND SECURED IT WITH SUTURES. ANOTHER INCISION WAS MADE INTO THE RIGHT INGUINAL FLOOR. THE HERNIA SAC WAS DISSECTED OUT. A 3DMAX MESH (DEVICE 2) WAS PLACED INTO THE RIGHT INGUINAL FLOOR AND SECURED IT WITH SUTURES." ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH BILATERAL REDUCIBLE RECURRENT INGUINAL HERNIAS, PAIN, THEREBY UNDERWENT LAPAROSCOPIC REPAIR OF A LEFT RECURRENT DIRECT INGUINAL HERNIA WITH IMPLANT OF UNKNOWN MESH AND REPAIR OF A RIGHT RECURRENT DIRECT INGUINAL HERNIA USING EXISTING OLD MESH (DEVICE 2). PER OPERATIVE NOTES, "AN INCISION WAS MADE INTO THE LEFT INGUINAL REGION. THE HERNIA SAC WAS DISSECTED OUT. AN UNKNOWN MESH WAS PLACED INTO THE LEFT INGUINAL REGION AND SECURED IT WITH SUTURES. ANOTHER INCISION WAS MADE INTO THE RIGHT INGUINAL FLOOR. THE HERNIA SAC WAS DISSECTED OUT.

  Patient problems: Hernia; Pain

  MAUDE report 25653294 ↗
• InjuryMay 12, 2026Migration

  PER INFORMATION PROVIDED: (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE 1). PER OP NOTES, "INCISION WAS MADE TO THE LEFT GROIN, A PERFIX PLUG (DEVICE 1) WAS PLACED TO THE PUBIC TUBERCLE." (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIAS AND UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF TWO 3DMAX MESH (DEVICE 2 AND 3). PER OP NOTES, "THE RIGHT SIDE WAS FOUND TO HAVE A DIRECT INGUINAL HERNIA THAT WAS REDUCED. THEN ATTENTION WAS TOWARDS THE LEFT SIDE WHERE THE PREVIOUS HERNIA REPAIR WAS DONE. A LARGE MESH PLUG PROTRUDING INTO THE PREPERITONEAL SPACE WAS FOUND THERE AND WAS MOST LIKELY TO THE PAIN THE PATIENT WAS EXPERIENCED. THIS MESH PLUG (DEVICE 1) WAS RESECTED. TWO 3DMAX MESH (DEVICE 2 AND 3) WERE PLACED ON BOTH LEFT AND RIGHT SIDE TO THE COOPER'S LIGAMENT USING TACKS. ATTENTION WAS DIRECTED TOWARDS THE UMBILICAL SITE THAT WAS DISSECTED." (B)(6) 2018 - PATIENT HAD CHRONIC GROIN PAIN THEREBY UNDERWENT LAPAROSCOPY. PER OP NOTES, "THE MESHES (DEVICE 2 AND 3) WERE IN PLACE, THEY APPEARED TO HAVE MIGRATED SUPERIORLY SLIGHTLY

  Patient problems: Pain

  MAUDE report 25153531 ↗
• InjuryApr 29, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH BILATERAL RECURRENT INGUINAL HERNIAS AND UMBILICAL HERNIA THEREBY UNDERWENT ROBOTIC REPAIR WITH THE IMPLANT OF 3DMAX MESHES (LEFT - DEVICE 1, RIGHT ¿ DEVICE 2). PER OP NOTES, "BILATERAL HERNIA WAS NOTED. A MEDIUM 3DMAX MESHES (DEVICE 1, 2) WAS PLACED BILATERALLY AND SECURED TO FASCIA USING SUTURES TO COVER ALL THE DEFECTS. THE UMBILICAL HERNIA WAS REPAIRED USING SUTURES." (B)(6) 2021 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF TWO BARD FLAT MESHES (DEVICE 3, 4). PER OP NOTES, "ON RIGHT INGUINAL CANAL, A DIRECT INGUINAL HERNIA WAS NOTED. PREVIOUS MESH (DEVICE 2) WAS PALPABLE ALONG THE INGUINAL FLOOR. A BARD FLAT MESH (DEVICE 3) WAS TRIMMED TO SIZE WITH A SLIT CUT IN KEYHOLE FASHION AND POSITIONED OVER THE HERNIA DEFECT USING SUTURE TO THE PUBIC TUBERCLE INFERIORLY AND SHELVING EDGE OF THE INGUINAL LIGAMENT. ON LEFT SIDE, SMALL DIRECT INGUINAL HERNIA WAS NOTED. A BARD FLAT MESH (DEVICE 4) WAS ALSO USED FOR THE LEFT INGUINAL HERNIA AND SECURED USING SUTURES."

  Patient problems: Hernia

  MAUDE report 25034187 ↗
• InjuryMar 17, 2026Patient-Device Incompatibility

  AS REPORTED PER ANSM REPORT (NO, (B)(4)) IN SUMMARY: AS REPORTED, THE PATIENT UNDERWENT RIGHT INGUINAL HERNIA REPAIR ON (B)(6) 2019 AND WAS IMPLANTED WITH A 3DMAX RIGHT MESH. AS REPORTED, THE PATIENT UNDERWENT LEFT INGUINAL HERNIA REPAIR ON (B)(6) 2019 AND WAS IMPLANTED WITH A 3DMAX LEFT MESH. DATE OF OCCURRENCE: (B)(6) 2019. DESCRIPTION OF THE INCIDENT: "FOLLOWING SEVERE, DEBILITATING PAIN, THE SURGEON TOLD ME THAT EVERYTHING WAS FINE, THE PLATES WERE IN PLACE, AND THAT I SHOULD SEE A GYNAECOLOGIST SPECIALIZING IN ENDOMETRIOSIS GIVEN MY SYMPTOMS. HE DID NOT WANT TO INVESTIGATE FURTHER, AS THE PAIN WAS NORMAL IN HIS OPINION. I UNDERWENT NUMEROUS INCONCLUSIVE, VERY PAINFUL, HUMILIATING AND UNANSWERED TESTS (PELVIC MRI, PELVIC ENDO ULTRASOUND, BRAIN MRI, SPINAL CORD MRI, ELECTROMYOGRAM, ETC.) AND VARIOUS TREATMENTS (VERY HEAVY, UP TO 34 MEDICATIONS AND A STAY IN A PSYCHIATRIC HOSPITAL). I SAW MANY SPECIALISTS IN ANGERS, TOURS AND LE MANS. SUPERFICIAL ENDOMETRIOSIS, FIBROMYALGIA, BLADDER PROBLEMS (NEUROSTIMULATOR IMPLANTED), IRRITABLE BOWEL SYNDROME (SIBO), AND SEVERE DEPRESSION ARE MY CONDITIONS, BUT I WILL SPARE YOU THE DETAILS." (B)(6) 2026 - MY SURGEON, REMOVED 4/5 OF THE PROSTHES

  Patient problems: Adhesion(s); Depression; Pain

  MAUDE report 24620820 ↗
• InjuryMar 12, 2026Patient-Device Incompatibility

  PER ANSM REPORT (B)(4) IN SUMMARY: DATE OF OCCURRENCE: (B)(6) 2026. THE PATIENT WAS DIAGNOSED WITH INGUINAL CYST AND SMALL HERNIA, AND OPERATED ON IN 2011, WITH SOME HEALING PROBLEMS AFTERWARDS. ABOUT 1YR LATER, HAD HERNIATED DISC THAT ¿PARALYZED ME FOR A WHILE, BUT GROIN PAIN WAS THERE.¿ AFTER REPEATEDLY URGING SPECIALISTS TO LOOK AT MY GROIN PROBLEM RATHER THAN MY BACK, A SURGEON AGREED TO OPERATE ON ME. HE WAS ONLY SUPPOSED TO PERFORM EXP LAP SURGERY, IN HIS OPINION, THERE WAS NOTHING WRONG WITH ME, BUT WHEN I WOKE UP, I FOUND MYSELF WITH A 3DMAX MESH. I DID HAVE EVENTRATION AND MULTIPLE PROBLEMS, ADHESIONS AROUND MY 1ST OPERATION SITE. HAPPY WITH THE RESULT AFTER A MONTH, WITH LOT OF EFFORT TO GET BACK INTO SHAPE AND RECOVER FROM MY HERNIATED DISC, PLUS BACK REHABILITATION, BUT MY LIFE IN GENERAL HAD CHANGED, I HAD TO ADAPT MY LIFESTYLE TO AVOID RECURRENCE. EXCERPT FROM SURGEON (B)(6) 2015-OUTPATIENT RIGHT INGUINAL EXPLORATION USING LAPAROSCOPY AND PRE-PERITONEAL TECHNIQUES FOR RESISTANT AND DEBILITATING RIGHT INGUINAL PAIN. IN 2013 THIS PATIENT UNDERWENT REMOVAL OF SPERMATIC CORD CYST COMBINED WITH TREATMENT FOR RIGHT INGUINAL HERNIA. THE PATIENT HAD DEBILITATING PAIN AROUND T

  Patient problems: Fatigue; Neuropathy; Paresthesia; Unspecified Kidney or Urinary Problem

  MAUDE report 24583639 ↗
• InjuryMar 2, 2026Migration

  PER INFORMATION PROVIDED: ON (B)(6) 2008 ¿ PATIENT WAS DIAGNOSED WITH SYMPTOMATIC RIGHT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX MESH (DEVICE 1). PER OPERATIVE NOTES, ¿IN THE RIGHT INGUINAL FLOOR THE HERNIA SAC WAS COMPLETELY DISSECTED FREE AND COMPLETELY REDUCED FROM THE CORD STRUCTURES. A PIECE OF MEDIUM SIZED 3DMAX MESH (DEVICE 1) WAS PLACED INTO THE ABDOMEN AND SECURED TO THE COOPER¿S LIGAMENT. THE PERITONEUM WAS REAPPROXIMATED AND SECURED WITH SUTURES.¿ ON (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG MESH (DEVICE 2). PER OPERATIVE NOTES, ¿IN THE MEDIAL HALF OF THE INGUINAL FLOOR, THE PRIOR MESH (DEVICE 1) WAS PALPABLE AND APPEARED PULLED AWAY FROM THE PUBIC TUBERCLE AND COOPER LIGAMENT AREA AND SLIGHTLY CURLED WITH DIRECT DEFECT MEDIALLY. THE DEFECT WAS CIRCUMFERENTIALLY REDUCED AND SMALL PERFIX PLUG (DEVICE 2) WAS PLACED INTO THE DEFECT AND SECURED WITH SUTURES. THE WOUND WAS IRRIGATED AND REAPPROXIMATED WITH SUTURES.¿ ON (B)(6) 2020 ¿ PATIENT WAS DIAGNOSED WITH RIGHT GROIN PAIN THEREBY UNDERWENT RIGHT GROIN EXPLORATION AND NEURECTOMY WITH PARTIAL EXCISION

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

  MAUDE report 24485035 ↗
• InjuryFeb 23, 2026Patient-Device Incompatibility

  PER ANSM USER REPORT (B)(4): DESCRIPTION OF THE INCIDENT: PERIOD SINCE OCCURRENCE SINCE THE IMPLANTATION ((B)(6) 2024) OF TWO (2) PROSTHESES (3DMAX MESH LEFT AND RIGHT) AS PART OF TREATMENT FOR BILATERAL INGUINAL HERNIAS, I HAVE EXPERIENCED OCCASIONAL ACUTE PAIN (URINARY AND/OR SPERMATIC FUNCTION) AND MILDER RECURRING PAIN ON A DAILY BASIS. ACTIONS TAKEN BY THE HEALTHCARE FACILITY TO TREAT THE PATIENT: NR. THIS FILE REPRESENTS 3DMAX MESH RIGHT.

  Patient problems: Dysuria; Pain

  MAUDE report 24413078 ↗
• InjuryJan 29, 2026Migration

  PER INFORMATION PROVIDED: (B)(6) 2013- PATIENT WAS DIAGNOSED WITH DIRECT RIGHT INGUINAL HERNIA AND PAIN, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 1). PER OP NOTES, ¿A SMALL DIRECT INGUINAL HERNIA WAS IDENTIFIED IN THE RIGHT INGUINAL REGION. A PERFIX PLUG (DEVICE 1) WAS PLACED INTO THE DIRECT SPACE AND SUTURED¿. (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA AND RIGHT GROIN PAIN, THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX MESH (DEVICE 2). PER OP NOTES, ¿A PIECE OF MESH THAT WAS WADDED INTO A BUNCH ALMOST LIKE A PLUG SO THE INFERIOR ASPECT HAD A PERSISTENT HERNIA. A 3DMAX MESH (DEVICE 2) WAS PLACED OVER THE HERNIA DEFECT, ACROSS THE PUBIC SYMPHYSIS AND WAS SUTURED¿. (B)(6) 2017- PATIENT WAS DIAGNOSED WITH PELVIC HEMATOMA AND PROSTATE CANCER, THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF PERFIX PLUG (DEVICE 1) AND 3DMAX MESH (DEVICE 2). PER OP NOTES, ¿ABDOMEN SHOWS DISPLACEMENT OF MESH (DEVICE 1- PERFIX PLUG, DEVICE 2- 3DMAX MESH) WHICH WAS SHARPLY REMOVED¿.

  Patient problems: Hematoma; Pain

  MAUDE report 24207018 ↗
• InjuryJan 13, 2026Patient-Device Incompatibility

  AS PER ANSM REPORT: (B)(4). SUMMARY OF REPORTED EVENT: (B)(6) 2025 ¿ PATIENT HAD BILATERAL INGUINAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF TWO BARD 3DMAX MESH (DEVICE 1, 2). PER OP NOTES, ¿BILATERAL DIRECT INGUINAL HERNIA WAS REVEALED. THE ANTERIOR PARIETAL PERITONEUM ABOVE THE HERNIAL SAC WAS DISSECTED. A 10.8X16CM BARD PROSTHESIS (DEVICE 1) ON THE LEFT AND AN 8.5X13.7CM PROSTHESIS (DEVICE 2) ON THE RIGHT WERE PLACED AND CLOSED USING SUTURES.¿ (B)(6) 2025 ¿PATIENT EXPERIENCED PAIN IN LOWER PELVIS WHICH RADIATED TO THE TESTICLES, INNER THIGH AND ANUS. AN ULTRASOUND AND PELVIC CT SCAN CONFIRMED THE RECURRENCE OF BOTH INGUINAL HERNIAS, AS WELL AS THE APPEARANCE OF A SMALL UMBILICAL HERNIA. (B)(6) 2025 ¿ PATIENT HAD DEBILITATING PAIN AND WAS DIAGNOSED WITH BILATERAL PRE-HERNIAL LIPOMA THEREBY UNDERWENT OPEN REPAIR. PER OP NOTES, ¿ON LEFT SIDE, THE SPERMATIC CORD IS IDENTIFIED AND LIGATED. DISSECTION OF THE PRE-HERNIAL LIPOMA CONFIRMED THE PRESENCE OF AN INDIRECT HERNIA WITH FATTY CONTENT. THE HERNIA WAS RESECTED. THE PARIETAL SUBSTANCE LOSS WAS REPAIRED BY PLACING AN UNKNOWN PROTHESIS WHICH FIXED TO PUBIC SPINE, CRURAL ARCH, TENDON JOINT USING SUTURES. ON RI

  Patient problems: Ambulation or Postural Difficulties; Hernia; Pelvic Pain; Unspecified Gastrointestinal Problem; Weight Changes

  MAUDE report 24052707 ↗
• InjuryJan 4, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF TWO 3DMAX MESH (DEVICE 1 AND 2). PER OP NOTES, "AN INCISION WAS MADE IN THE RIGHT LOWER QUADRANT, A 3DMAX MESH (DEVICE 1) WAS PLACED INTO THE DEFECT USING PROLENE SUTURES. A SECOND PIECE OF 3DMAX MESH (DEVICE 2) WAS PLACED TO THE MIDLINE USING TACKS." ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT REPAIR. PER OP NOTES, "AN INCISION WAS MADE THROUGH AN OLD SCAR IN THE RIGHT LOWER QUADRANT AND CARRIED DOWN. ENCOUNTERED THE OLD MESH (DEVICE 1 AND 2), WHICH WAS ADHERENT TO THE FLOOR ALL THE WAY DOWN TO THE SYMPHYSIS PUBIS. A SYNTHETIC MESH WAS PLACED."

  Patient problems: Adhesion(s); Hernia; Scar Tissue

  MAUDE report 23953907 ↗
• InjuryDec 18, 2025Material Deformation; Migration; Material Deformation; Migration

  PER INFORMATION PROVIDED: (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED REPAIR WITH IMPLANT OF 3DMAX MESH (DEVICE 1 AND DEVICE 2). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND DISSECTED. A LARGE 3DMAX MESH (DEVICE 1 AND DEVICE 2) WERE PLACED INTO THE ABDOMEN, AND THIS WAS ALIGNED OVER THE HERNIA SPACE TO COVER BOTH THE DIRECT, THE INDIRECT AND FEMORAL SPACES WITH OVERLAP ONTO COOPER¿S LIGAMENT AND TACKED.¿ (B)(6) 2020 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT ROBOTIC ¿ ASSISTED LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX MESH (DEVICE 3). PER OPERATIVE NOTES, ¿A RIGHT SIDED 3DMAX MESH (DEVICE 1 AND DEVICE 2) THAT APPEARED TO HAVE FOLDS LATERALLY AND INFERIORLY. IT WAS AN EARLY RECURRENCE WITH A SMALL HERNIA DEFECT BUT CERTAINLY NOT IN APPROPRIATE POSITION. IT WAS FOLDED AND MALPOSITIONED. A LARGE 3DMAX MESH (DEVICE 3) WAS PLACED INTO THE HERNIA SPACE WITH GOOD MEDIAL COVERAGE OF COOPER¿S LIGAMENT AND THE FEMORAL CANAL. THE MESH WAS TUCKED IN FRONT OF THE OLD MESH AND POSITIONED SO THE BOTTOM HALF OF THE NEW MESH AND OLD MESH WOULD OVERLAP AND SEWED THE TWO PIECES OF MESH TOGETHER.¿

  Patient problems: Hernia

  MAUDE report 23836364 ↗
• InjuryAug 1, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2004 ¿ PATIENT WAS DIAGNOSED WITH RIGHT DIRECT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿IN THE DIRECT SPACE, HERNIA WAS APPARENT AND REDUCED. A 3DMAX MESH (DEVICE #1) WAS PLACED AND SUTURED.¿ (B)(6) 2005 ¿ PATIENT UNDERWENT RIGHT INGUINAL HERNIA REPAIR. (NOTE: THERE IS NO OPERATIVE NOTES PROVIDED FOR THIS PROCEDURE IN MEDICAL RECORDS) (B)(6) 2008 ¿ PATIENT UNDERWENT LEFT INGUINAL HERNIA REPAIR. (NOTE: THERE IS NO OPERATIVE NOTES PROVIDED FOR THIS PROCEDURE IN MEDICAL RECORDS) (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE #2). PER OPERATIVE NOTES, ¿BOTH DIRECT AND INDIRECT INGUINAL HERNIA WAS IDENTIFIED. A PERFIX PLUG (DEVICE #2) WAS PLACED AND SECURED WITH SUTURES.¿ (B)(6) 2010 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT DIRECT LEFT INGUINAL HERNIA AND PAIN THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿RECURRENCE IN DIRECT SPACE WAS NOTED AND MESH (DEVICE #2) APPEARED TO HAVE COME AWAY SUPERIOR. A SYNTHETIC MESH WAS PLACED IN THE PREPERITONEAL SPACE AND SUTURED.¿

  Patient problems: Hernia

  MAUDE report 22685778 ↗
• InjuryJul 30, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF 3DMAX MESH (DEVICE #1 ¿ LEFT, DEVICE #2 ¿ RIGHT). PER OP NOTES, ¿ON LEFT, INGUINAL HERNIA WAS TAKEN DOWN AND A MEDIUM 3DMAX MESH (DEVICE #1) WAS PLACED AND SECURED TO THE COOPER LIGAMENT AND EPIGASTRIC VESSELS. ON RIGHT, A 3DMAX MESH (DEVICE #2) WAS PLACED AS A SIMILAR FASHION OF LEFT AND TACKED.¿ (B)(6) 2013 -PATIENT HAD CHRONIC GROIN PAIN THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF TACKS. PER OP NOTES, ¿ON THE RIGHT SIDE, THE TACKS WERE UNSCREWED AND REMOVED. ON LEFT, THICKENED MESH (DEVICE #1) WAS NOTED.¿ (B)(6) 2014 ¿ PATIENT WAS DIAGNOSED WITH BILATERAL RECURRENT INGUINAL HERNIA AND INGUINODYNIA THEREBY UNDERWENT OPEN REPAIR WITH THE PARTIAL REMOVAL OF MESH (DEVICE #1, #2). PER OP NOTES, ¿ON RIGHT, LAPAROSCOPIC MESH (DEVICE #2) IN THE PREPERITONEAL SPACE LINEAR SEGMENT WAS REMOVED AND SHOULDICE REPAIR WAS DONE USING SUTURES. EXACT SAME PROCEDURE WAS DONE ON LEFT SIDE AND MESH (DEVICE #1) WAS REMOVED. THEN, THE ABDOMINAL WALL INFECTION WAS NOTED.¿ (B)(6) 2015 ¿ PATIENT WAS DIAGNOSED WITH BILATERAL INGUINODYNIA, BILATERAL NE

  Patient problems: Adhesion(s); Hernia; Unspecified Infection

  MAUDE report 22662995 ↗
• InjuryJul 25, 2025Migration; Migration

  AS REPORTED, ON (B)(6) 2025 THE PATIENT UNDERWENT LAPAROSCOPIC REPAIR (TEP TECHNIQUE) OF BILATERAL INGUINAL HERNIAS. AS REPORTED A 3DMAX MESH WAS USED FOR THE RIGHT SIDED REPAIR AND THE SURGEON FIXATED THE MESH. REPORTEDLY, "THE MESH MIGRATED AND IT APPEARS THE PATIENT MAY HAVE AN EARLY RECURRENCE." THE PATIENT'S CONDITION IS STABLE; HOWEVER, THE SURGEON IS PLANNING A REVISION PROCEDURE. THE SURGEON REPORTS HE IS A FIRST TIME USER TO THE 3DMAX MESH AND WAS UNSURE WHETHER THE ISSUE WAS TECHNIQUE OR MESH RELATED.

  Patient problems: Hernia

  MAUDE report 22614720 ↗
• InjuryJul 21, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2005 ¿ PATIENT WAS DIAGNOSED WITH LEFT DIRECT AND RIGHT INDIRECT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF 3DMAX MESH (DEVICE #1 ¿ RIGHT, DEVICE #2 ¿ LEFT). PER OP NOTES, ¿THE INDIRECT HERNIA SAC ON THE RIGHT AND DIRECT SAC ON LEFT WAS IDENTIFIED. ON EACH SIDE, A MEDIUM 3DMAX MESH (DEVICE #1, #2) WAS PLACED TO HERNIA DEFECT AND SUTURED.¿ FROM (B)(6) 2018 TO (B)(6) 2019 ¿ PATIENT HAD ABDOMINAL PAIN SECONDARY TO INGUINAL HERNIA MESH WERE TREATED WITH ANTIBIOTICS.

  Patient problems: Abdominal Pain

  MAUDE report 22552994 ↗
• InjuryJul 18, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2015 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED RIGHT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF TWO 3DMAX MESH (DEVICE #1 AND #2). PER OPERATIVE NOTES, ¿HERNIA SAC WAS DISSECTED COMPLETELY AND HERNIA WAS REPAIRED WITH TWO 3DMAX MESH. THE FIRST 3DMAX MESH (DEVICE #1) WAS INSERTED WITH CORD SLIT AND OTHER 3DMAX MESH (DEVICE #2) WAS PLACED OVER THE FIRST MESH (DEVICE #1) AS BUTTRESS REPAIR WITH SUTURES.¿ ON (B)(6) 2018¿ PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE #3). PER OPERATIVE NOTES, ¿THE MASS WAS IDENTIFIED AT THE PUBIC TUBERCLE AND NOTED TO BE CLOSELY ADHERENT TO THE OVAL MESH (DEVICE #1 AND #2). THE MASS WAS EXCISED. RECURRENT INDIRECT INGUINAL HERNIA WAS IDENTIFIED AND PLACED WITH PERFIX PLUG (DEVICE #3) AND SECURED WITH SUTURES.¿

  Patient problems: Adhesion(s); Hernia

  MAUDE report 22540277 ↗
• InjuryJun 26, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED BY ANSM IN SUMMARY: A 49-YEAR-OLD MALE PATIENT UNDERWENT LAPAROSCOPIC REPAIR OF BILATERAL INGUINAL HERNIA WITH TWO 3DMAX MESHES (DEVICE #1 AND #2) AND SIMPLE UMBILICAL HERNIA REPAIR ON (B)(6) 2024. PER NOTES, ¿THE MIXED TYPE RIGHT INGUINAL HERNIA WAS REPAIR USING 3DMAX MESH AND WELL POSITIONED IN PREPERITONEAL SPACE. THE SAME PROCEDURE FOR DIRECT LEFT INGUINAL HERNIA. UMBILICAL HERNIA WAS REPAIRED USING STITCHES.¿ IT WAS REPORTED PATIENT FELT STRONG PAIN LOWER ABDOMEN AS SOON AS WOKE UP FROM THE OPERATION. PATIENT ALSO EXPERIENCED PAIN, CONSTIPATION, BLOATING, ABDOMINAL HARDENING, SWELLING, ABNORMAL HEARTBEATS, ERECTILE DYSFUNCTION. SINCE THE OPERATION, PATIENT REPORTED TO HAVE UNDERGONE NUMEROUS MEDICAL EXAMINATIONS (MRI, SCANS, BLOOD TESTS, ETC.), WITHOUT A CLEAR AND COHERENT DIAGNOSIS BEING ESTABLISHED. IT WAS ALSO REPORTED THAT THE PATIENT CURRENTLY TAKING ANTIDEPRESSANTS, ANXIOLYTICS AND SLEEPING PILLS. PATIENT'S CURRENT CONDITION: "DESPITE CONSULTATIONS WITH SEVERAL SPECIALISTS: PAIN, GASTRO ENTEROLOGIST, RADIOLOGIST, ULTRASONOGRAPHER, GENERAL PRACTITIONER, SURGEON...MY LIFE HAS BEEN HELL SINCE (B)(6) 2024, THE DATE THESE PROSTHESES WERE FITTED. I WAS NEVER INFORM

  Patient problems: Constipation; Pain; Unspecified Infection

  MAUDE report 22343081 ↗
• InjuryMar 6, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: ON (B)(6) 2015, PATIENT WAS DIAGNOSED WITH BILATERAL SYMPTOMATIC INGUINAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC TOTAL EXTRAPERITONEAL REPAIR WITH THE IMPLANT OF 3DMAX MESHES (DEVICE #1 & #2). PER OPERATIVE NOTES, "ON RIGHT SIDE, THERE WAS SCAR TISSUE AND THE POSTERIOR PERITONEUM WAS STUCK IN THE AREA. A DIRECT INGUINAL HERNIA WAS NOTED, A 3DMAX MESH (DEVICE #1) WAS POSITIONED AND TACKED TO THE PUBIC TUBERCLE AND ROLLED OUT OVER THE INGUINAL HERNIA AND TUCKED INTO THE SULCUS. ON LEFT SIDE, AN INDIRECT HERNIA WAS PULLED DOWN AND SWEPT OFF THE CORD AND REDUCED. ANOTHER 3DMAX MESH (DEVICE #2) WAS TACKED DOWN LATERALLY AND INFERIORLY INTO SULCUS COVERING THE DEFECT." ON (B)(6) 2015, PATIENT VISITED HOSPITAL FOR PAIN AND WAS DIAGNOSED WITH LEFT INGUINAL HERNIA. ON (B)(6) 2015, PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INDIRECT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX LIGHT PLUG (DEVICE #3). PER OPERATIVE NOTES, "THE HERNIA SAC WAS IDENTIFIED, THICKENED AND SCARRED. THE PREVIOUSLY PLACED MESH (DEVICE #2) WAS IDENTIFIED MEDIALLY AND INFERIORLY. A PERFIX LIGHT PLUG (DEVICE #3) WAS PLACED IN PREPERITONEAL SPACE AND SUTURED. THE ONLAY

  Patient problems: Abdominal Pain; Hernia; Obstruction/Occlusion

  MAUDE report 21535633 ↗
• InjuryAug 26, 2024Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL 3DMAX MESH ON (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE 3DMAX MESH. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 20062835 ↗
• InjuryAug 23, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2016 - PATIENT UNDERWENT LAPAROSCOPIC BILATERAL INGUINAL HERNIA REPAIR WITH THE IMPLANT OF TWO 3DMAX MESHES (DEVICE #1 & #2). PER OPERATIVE NOTES, ¿SAC WAS DISSECTED COMPLETELY AND REPAIRED WITH 3DMAX MESHES." (B)(6) 2017 - PATIENT UNDERWENT ULTRASOUND WHICH SUGGEST BILATERAL INDIRECT INGUINAL HERNIA LARGER ON THE RIGHT SIDE THAN LEFT. (B)(6) 2017 - PATIENT HAD PRESSURE ON GROIN WITHOUT ANY PAIN AND THERE WAS NO EVIDENCE OF HERNIA.

  Patient problems: Hernia

  MAUDE report 20046305 ↗
• InjuryDec 15, 2023Device Appears to Trigger Rejection; Defective Device; Patient Device Interaction Problem; Device Appears to Trigger Rejection; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL 3DMAX MESH ON (B)(6) 2015. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE 3DMAX MESH. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Insufficient Information; Nerve Damage; Pain

  MAUDE report 18333390 ↗
• InjuryNov 29, 2023Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL 3DMAX ON (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE 3DMAX. ATTORNEY ALLEGES THAT THE PATIENT HAD REVISION SURGERY ON (B)(6) 2023. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Insufficient Information; Pain

  MAUDE report 18225284 ↗
• InjuryOct 20, 2023Defective Device; Material Deformation; Patient Device Interaction Problem; Migration; Defective Device; Material Deformation; Patient Device Interaction Problem; Migration

  PER INFORMATION PROVIDED BY THE ATTORNEY: (B)(6) 2013 - PATIENT HAD PREVIOUSLY UNDERGONE RIGHT INGUINAL HERNIA REPAIR WITH THE IMPLANT OF A SYNTHETIC MESH ON (B)(6) 2012 AND NOW DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG AND PATCH (DEVICE #1). PER OPERATIVE NOTES, ¿DISSECTED THE HERNIA SAC CONTENTS OFF OF THE HERNIA SAC, THEN REDUCED THE HERNIA CONTENTS BACK INTO THE PREPERITONEAL SPACE AND PLACED A PERFIX PLUG AND PATCH (DEVICE #1). PLACED A ONLAY MESH TO APPROXIMATE THE SHELVING EDGE WITH THE CONJOINED TENDON ABOVE A MESH.¿ (B)(6) 2014 - PATIENT VISITED HOSPITAL FOR PAIN. (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RIGHT GROIN PAIN, RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG AND PATCH (DEVICE #2). PER OPERATIVE NOTES, ¿THERE WAS SLIGHT BULGING OF THE INGUINAL CONTENTS AND SMALL DEFECT OF THE DEEP RING. PLACED A MEDIUM PERFIX PLUG (DEVICE #2) AND SECURED WITH SUTURE. PATCH WAS THEN PLACED OVER THE TOP OF THIS AND SECURED WITH SUTURE TO THE PUBIC TUBERCLE, THE ILIOINGUINAL LIGAMENT AND THE CONJOINED TENDON.¿ (NOTE: THERE IS NO MENTION/VISUALIZATION OF MESH IN OPERATIVE

  Patient problems: Adhesion(s); Drug Resistant Bacterial Infection; Hematoma; Hernia; Neuralgia; Seroma

  MAUDE report 17975056 ↗