3DMAX 0115310Recalls & reported problems

Summary

The FDA's MAUDE database contains 125 adverse event reports that list this exact device (DI 00801741030727), received between Jul 13, 2015 and Sep 30, 2026 — classified as 118 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Defective Device” (92 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 125 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Patient-Device Incompatibility

  Patient problems: Ambulation or Postural Difficulties; Depression; Dyspareunia; Fatigue; Hernia; Muscle Weakness/Atrophy; Pain; Unspecified Gastrointestinal Problem

  MAUDE report 50950925 ↗
• InjurySep 30, 2026Patient-Device Incompatibility

  Patient problems: Cognitive Changes; Fatigue; Muscle Weakness/Atrophy; Pain; Unspecified Gastrointestinal Problem

  MAUDE report 50950923 ↗
• InjuryJun 30, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX MESH (DEVICE 1 - LEFT AND DEVICE 2 - RIGHT). PER OPERATIVE NOTES, "AN INCISION WAS MADE INTO THE LEFT INGUINAL REGION. THE HERNIA SAC WAS DISSECTED OUT. A 3DMAX MESH (DEVICE 1) 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. A 3DMAX MESH (DEVICE 2) WAS PLACED INTO THE RIGHT INGUINAL FLOOR AND SECURED IT WITH SUTURES." (B)(6) 2021 - PATIENT WAS DIAGNOSED WITH RECURRENT BILATERAL INGUINAL HERNIA, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF PERFIX LIGHT PLUG (DEVICE 3 - LEFT AND DEVICE 4 - RIGHT). PER OPERATIVE NOTES, "A TRANSVERSE INCISION WAS MADE INTO THE LEFT INGUINAL REGION. THE HERNIA SAC WAS DISSECTED OUT. A PERFIX LIGHT PLUG (DEVICE 3) WAS PLACED INTO THE LEFT INGUINAL FLOOR AND SECURED IT WITH SUTURES. ANOTHER TRANSVERSE INCISION WAS MADE INTO THE RIGHT INGUINAL REGION. THE HERNIA SAC WAS DISSECTED OUT. A PERFIX LIGHT PLUG (DEVICE 4) WAS PLACED INTO THE RIGHT INGUINAL FLOOR AND SECURED IT WITH SUTURES."

  Patient problems: Hernia

  MAUDE report 25668606 ↗
• MalfunctionJun 16, 2026Unsealed Device Packaging

  AS REPORTED, DURING A PROCEDURE USING 3DMAX MESH IT WAS NOTICED THAT THE INNER STERILE PACKAGE WAS "LEAKING AIR". REPORTEDLY THE PRODUCT WAS OBSERVED TO HAVE LEAKAGE AT THE EDGES OF THE PACKAGING, THE OUTER BOX WAS COMPLETELY SEALED PRIOR TO OPENING, AND THE PRODUCT HAD NOT BEEN OPENED BEFORE USE IN THE OPERATING ROOM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25524204 ↗
• InjuryJun 2, 2026Material Deformation

  PER INFORMATION PROVIDED: ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH NON-RECURRENT UNILATERAL LEFT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX MESH (DEVICE 1). PER OP NOTES, "AN INCISIONAL HERNIA WAS OBSERVED AND REDUCED FROM THE SITE OF PREVIOUS INGUINAL INCISION. THE HERNIA SAC WAS REDUCED. A LEFT SIDED MEDIUM 3DMAX MESH (DEVICE 1) WAS PLACED INTO THE PREPERITONEAL SPACE AND OVER THE POSTERIOR INGUINAL FLOOR USING SUTURES." ON (B)(6) 2018- PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT AN OPEN REPAIR WITH EXPLANT OF 3DMAX (DEVICE 1) AND IMPLANT OF BARD FLAT MESH (DEVICE 2). PER OP NOTES, "THE PREVIOUS PREPERITONEAL MESH (DEVICE 1) WAS ENCOUNTERED AND FOUND TO BE BALLED UP WAS REMOVED. THE HERNIA SAC WAS THEN REDUCED. A BARD FLAT MESH (DEVICE 2) WAS CUT TO SIZE AND LAID OVER THE LAYER AND SECURED TO THE PUBIC TUBERCLE USING SUTURES.". ON (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT AN OPEN REPAIR WITH REMOVAL OF MESH (DEVICE 2) AND IMPLANT OF 3DMAX MESH (DEVICE 3). PER OP NOTES, "A LEFT INGUINAL INCISION WAS MADE. THE OLD MESH (DEVICE 2) WAS REMOVED. A 3DMAX MESH (DEVICE 3) W

  Patient problems: Hernia

  MAUDE report 25364463 ↗
• 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." ON (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." ON (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 SL

  Patient problems: Pain

  MAUDE report 25153535 ↗
• InjuryApr 16, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA AND UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF TWO 3DMAX MESHES (DEVICE 1 AND 2). PER OPERATIVE NOTES, "THE HERNIA SACS IN THE RIGHT AND LEFT INGUINAL AREA WERE REDUCED AND SPERMATIC CORDS WERE SKELETONIZED. THE MEDIUM 3DMAX MESH (DEVICE 1- LEFT) AND MEDIUM 3DMAX MESH (DEVICE 2- RIGHT) WAS PLACED INTO THE PRE-PERITONEAL SPACE AND FIXED TO THE COOPER¿S LIGAMENT AND ANTERIOR ABDOMINAL WALL WITH TACKS. THE FASCIA WAS CLOSED AND SECURED WITH SUTURES AND TACKS. THE UMBILICAL HERNIA IN THE INFRAUMBILICAL AREA WAS NOTED. THE SAC WAS REDUCED AND RESECTED CIRCUMFERENTIALLY. THE FASCIAL DEFECT WAS CLOSED AND SECURED WITH SUTURES." ON (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH RECURRENT BILATERAL INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF TWO PERFIX PLUGS (DEVICE 3 AND 4). PER OPERATIVE NOTES, "IN THE LEFT INGUINAL AREA, A LARGE DIRECT HERNIA AND LARGE LIPOMA OF THE LEFT CORD WAS NOTED. THE HERNIA WAS REDUCED AND CORD STRUCTURES WERE DISSECTED. A LARGE PERFIX PLUG (DEVICE 3) WAS PLACED ALONG THE FLOOR OF THE INGUINAL CANAL AND SUTURED IN PLACE WITH SUTUR

  Patient problems: Hernia

  MAUDE report 24894081 ↗
• 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. 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 PROSTHESIS ON THE RIGHT SIDE. HE COULDN'T

  Patient problems: Depression; Pain

  MAUDE report 24620828 ↗
• InjuryFeb 27, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2009- PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX MESH (DEVICE 1 AND 2). PER OP NOTES, ¿ON THE RIGHT INGUINAL REGION, AN INDIRECT DEFECT WAS IDENTIFIED AND THE HERNIA WAS REDUCED. A 3DMAX MESH (DEVICE 1) WAS PLACED INTO THAT AREA AND TACKED. ON THE LEFT INGUINAL REGION A 3DMAX MESH (DEVICE 2) WAS PLACED INTO THE ABDOMINAL CAVITY AND TACKED IT IN PLACE.¿. ON (B)(6) 2013- PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 3). PER OP NOTES, ¿THE ILIOINGUINAL NERVE WAS DISSECTED OUT AND PRESERVED. THERE WAS A DIRECT HERNIA PRESENT IN THE RIGHT INGUINAL REGION WHICH WAS DISSECTED. THE PREVIOUSLY PLACED MESH WAS PALPABLE AND A SMALL DEFECT WAS NOTED BETWEEN MESH AND PUBIC TUBERCLE. THE PATCH FROM THE PERFIX PLUG (DEVICE 3) WAS PLACED ON THE DEFECT AND SUTURED. OF NOTE, THE PLUG MESH WAS NOT USED¿. ON (B)(6) 2015- PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF UNKNOWN MESH. PER OP NOTES, ¿ON THE LEFT INGUINAL REGION, THE ILIOINGUINAL NERVE

  Patient problems: Hernia; Nerve Damage

  MAUDE report 24466491 ↗
• InjuryFeb 23, 2026Patient-Device Incompatibility

  PER ANSM USER REPORT (B)(4): DESCRIPTION OF THE INCIDENT: PERIOD SINCE OCCURRENCE SINCE THE IMPLANTATION ((B)(4) 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 LEFT.

  Patient problems: Dysuria; Pain

  MAUDE report 24413079 ↗
• InjuryFeb 20, 2026Patient-Device Incompatibility

  AS REPORTED PER ANSM REPORT NO. (B)(4): DESCRIPTION OF THE INCIDENT: TESTICULAR VEIN THROMBOSIS CHRONIC GROIN/TESTICULAR PAIN. EXCERPT FROM THE OUTPATIENT SURGERY REPORT - DIGESTIVE AND ENDOCRINE SURGERY DEPARTMENT DATE OF PROCEDURE: (B)(6) 2023. LEFT INGUINAL HERNIA REPAIR BY LAPAROSCOPY CLINICAL SUMMARY: THIS IS A 30-YEAR-OLD PATIENT WITH NO PARTICULAR MEDICAL HISTORY. I OPERATED ON HIM A LITTLE LESS THAN A YEAR AGO FOR A RIGHT INGUINAL HERNIA. A FEW WEEKS AGO, FOLLOWING WEIGHT TRAINING, HE EXPERIENCED SHARP PAIN IN HIS LEFT GROIN. SINCE THEN, HE HAS EXPERIENCED PAIN WHENEVER HE LIFTS HEAVY LOADS. HE DESCRIBED MINIMAL PAIN IN THE RIGHT ILIAC FOSSA AND ABOVE THE NAVEL. HE PERFORMED AN ULTRASOUND SCAN, WHICH REVEALED A LEFT INGUINAL HERNIA WITH FATTY CONTENT AND A NECK MEASURING APPROXIMATELY 8 MM. THERE WERE NO ABNORMALITIES ON THE RIGHT SIDE. CLINICALLY, A VERY SMALL LEFT INGUINAL HERNIA IS PALPABLE AND PAINFUL ON PALPATION. I DO NOT FEEL ANY RECURRENCE ON THE RIGHT SIDE OR ANY ABNORMALITIES ON THE SUPRAPUBIC LINEA ALBA. HE HAS NORMAL BOWEL MOVEMENTS. THERE IS THEREFORE AN INDICATION FOR OUTPATIENT LAPAROSCOPIC REPAIR OF A LEFT INGUINAL HERNIA ACCORDING TO TEP. HE WILL PERFORM AN

  Patient problems: Pain; Thrombosis/Thrombus

  MAUDE report 24405084 ↗
• InjuryFeb 18, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA AND INCARCERATED UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF TWO 3DMAX MESHES (DEVICE 1 AND 2) AND VENTRALIGHT ST MESH (DEVICE 3). PER OPERATIVE NOTES, ¿ IN THE RIGHT INGUINAL AREA, HERNIA SAC WAS DISSECTED IN A POSTERIOR FASHION AND 3DMAX MESH (DEVICE 1 ¿ RIGHT) WAS PLACED IN PREPERITONEAL SPACE AND SECURED WITH SUTURES. IN THE LEFT SIDE, SIMILARLY HERNIA SAC WAS REMOVED AND ANOTHER 3DMAX MESH (DEVICE 2-LEFT) WAS PLACED AND SUTURED. THE INCARCERATED UMBILICAL HERNIA WAS REDUCED AND DEFECT WAS CLOSED WITH SUTURES. A VENTRALIGHT ST MESH (DEVICE 3) WAS PLACED INTO THE PERITONEAL CAVITY AND SECURED TRANSFASCIALLY WITH SUTURES AND TACKS. THE FASCIA WAS CLOSED AND SECURED WITH SUTURES.¿ (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RIGHT INGUINODYNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH REMOVAL OF RIGHT GROIN MESH (DEVICE 1) AND IMPLANT OF A SYNTHETIC AND BIOLOGICAL MESH. PER OPERATIVE NOTES, ¿OMENTAL ADHESIONS WERE REMOVED AND ALMOST ALL MESH (DEVICE 1) WAS REMOVED AND SMALL PIECE OF MESH (DEVICE 1) ON ILIAC VESSELS WAS LEFT INSITU. THE FASCIA WAS CLOSED WITH SUTURES

  Patient problems: Adhesion(s); Pain

  MAUDE report 24376494 ↗
• MalfunctionFeb 12, 2026Material Split, Cut or Torn

  AS REPORTED, DURING A UNILATERAL INGUINAL HERNIA REPAIR PROCEDURE, UPON OPENING THE PACKAGING, A "DAMAGED" 3DMAX MESH WAS DISCOVERED. HOWEVER, THE OUTER PACKAGING WAS FOUND INTACT WITH NO LEAKS AND WITHIN ITS EXPIRATION DATE. ANOTHER MESH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24319976 ↗
• InjuryJan 8, 2026Patient-Device Incompatibility

  PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2015 ¿ PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED REPAIR WITH THE IMPLANT OF 3DMAX MESHES (DEVICE 1, 2). PER OP NOTES, ¿ON RIGHT, THERE WAS AN INDIRECT AND DIRECT HERNIA. ON LEFT, A DIRECT HERNIA WAS NOTED. A MEDIUM 3DMAX MESHES (DEVICE 1, 2) WERE PLACED IN EACH PERITONEAL POCKET BILATERALLY AND CLOSED WITH SUTURES.¿ ATTORNEY ALLEGES HERNIA RECURRENCE, INFECTION, PAIN AND ALSO ALLEGED THAT PATIENT HAD NERVE PAIN THEREBY UNDERWENT PAIN MANAGEMENT.

  Patient problems: Hernia; Neuralgia; Unspecified Infection

  MAUDE report 24005787 ↗
• InjuryNov 21, 2025Migration; Migration

  PER INFORMATION PROVIDED: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX (DEVICE 1 AND 2). PER OP NOTES, ¿AN INDIRECT HERNIA SAC WAS NOTED ON RIGHT INGUINAL REGION WAS NOTED AND DISSECTED FREE. A 3DMAX (DEVICE 1) WAS PLACED AND TACKED USING SUTURES. AN INDIRECT HERNIA SAC WAS NOTED ON LEFT INGUINAL REGION AND REDUCED. A 3DMAX (DEVICE 2) WAS PLACED AND TACKED USING SUTURES.¿ (B)(6) 2018 ¿ PATIENT HAD PAIN THEREBY PROVIDED WITH MEDICATIONS. ATTORNEY ALLEGES PATIENT HAD HERNIA RECURRENCE, ADHESIONS, SEROMA, PAIN, MESH MIGRATION AND MESH SHRINKAGE. IT ALSO ALLEGED THAT PATIENT HAD PAIN CONTINUOUS TO WORSEN.

  Patient problems: Adhesion(s); Hernia; Seroma

  MAUDE report 23615801 ↗
• MalfunctionNov 11, 2025Use of Device Problem; Use of Device Problem

  AS REPORTED, ON (B)(6) 2025 DURING AN INGUINAL HERNIA REPAIR PROCEDURE THE PATIENT WAS IMPLANTED WITH A 3DMAX MESH. AS REPORTED IT WAS LATER IDENTIFIED THAT THE MESH HAD A LABELED EXPIRATION DATE OF (B)(6) . THERE WAS NO REPORTED PATIENT INJURY, CHANGE IN COURSE OF TREATMENT, OR ANY MEDICAL/SURGICAL INTERVENTION DUE TO THE ISSUE; THE MESH REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23521283 ↗
• InjuryJul 1, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL AND RIGHT FEMORAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF TWO 3DMAX MESH (RIGHT ¿ DEVICE #1 AND LEFT ¿ DEVICE #2). PER OPERATIVE NOTES, ¿TWO 3DMAX MESH (RIGHT ¿ DEVICE #1 AND LEFT ¿ DEVICE #2) WAS PLACED AND SUTURED.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH CHRONIC POSTOPERATIVE PAIN, ADHESION THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE EXPLANT OF RIGHT 3DMAX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿NO HERNIA SAC WAS NOTED. RIGHT SIDE 3DMAX MESH (DEVICE #1) WAS REMOVED.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH CHRONIC POSTOPERATIVE PAIN, RIGHT GENITOFEMORAL NEURALGIA, FIBROMYALGIA, ADHESION THEREBY UNDERWENT ROBOTIC ASSISTED REPAIR WITH THE EXPLANT OF LEFT SIDE 3DMAX MESH (DEVICE #2). PER OPERATIVE NOTES, ¿LEFT SIDE 3DMAX MESH (DEVICE #2) WAS REMOVED.¿

  Patient problems: Adhesion(s); Pain

  MAUDE report 22370105 ↗
• 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 (PROFANITY) SINCE (B)(6) 2024, THE DATE THESE PROSTHESES WERE FITTED. I WAS NEVER

  Patient problems: Constipation; Pain; Unspecified Infection

  MAUDE report 22343082 ↗
• InjuryMay 2, 2025Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  PER INFORMATION PROVIDED: ON (B)(6) 2005 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA- RIGHT DIRECT , LEFT INDIRECT HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX MESH (DEVICE #1- RIGHT AND DEVICE #2- LEFT). PER OPERATIVE NOTES, ¿IN RIGHT SIDE, THE PERINEUM OVER THE INDIRECT RING WAS INCISED AND DISSECTED AWAY FROM INTERNAL RING AND CORD STRUCTURES. A MEDIUM SIZE BARD 3D MESH (DEVICE #1- RIGHT) WAS PLACED OVER THE COOPER¿S LIGAMENT COVERING THE INDIRECT DEFECT AND AREA OF THE INTERNAL RING AND TACKED. IN LEFT SIDE, THE INDIRECT SAC WAS REDUCED, PERITONEUM WAS FURTHER DISSECTED AND PLACED WITH MEDIUM SIZE BARD 3D MESH (DEVICE #2- LEFT) OVER THE COOPER¿S LIGAMENT COVERING BOTH THE DEFECT AS WELL AS THE INDIRECT DEFECT." ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA AND RIGHT GROIN PAIN THEREBY UNDERWENT OPEN REPAIR WITH NEUROLYSIS. PER OPERATIVE NOTES, ¿THE MESH CAUSED BULGING THROUGH THE FLOOR OF THE INGUINAL CANAL IN LEFT SIDE. THE MESH WAS ALSO NOTED TO NOT BE ATTACHED TO ANYTHING AT THE INFERIOR ASPECT, AND A TACK COULD BE SEEN PROTRUDING. THE METALLIC CORKSCREW TACK WAS REMOVED. THE HERNIA WAS PRIMILARLY REPAIRED USING S

  Patient problems: Hernia

  MAUDE report 21949458 ↗
• InjuryApr 23, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF TWO 3DMAX MESH (DEVICE #1, #2). PER OPERATIVE NOTES, ¿ON RIGHT, THE HERNIA DEFECT WAS IDENTIFIED. ON LEFT, HERNIA WAS IDENTIFIED AT COOPER LIGAMENT AND HERNIA SAC WAS REDUCED. A MEDIUM 3DMAX MESH (DEVICE #1)WAS PLACED HERNIA DEFECT ON THE RIGHT SIDE AND TACKED IN ANTERIOR ABDOMINAL WALL AND THEN PLACED A LEFT SIDED 3DMAX MESH (DEVICE #2) AND TACKED TO COOPER LIGAMENT.¿ (B)(6) 2017 - PATIENT HAD A LARGE FLUID COLLECTION AROUND AREA OF INGUINAL HERNIA REPAIRS. THERE IS A PURULENT FLUID IN DRAINAGE. (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH ABSCESS, RECURRENT BILATERAL HERNIAS, INFECTED MESH THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESHES (DEVICE #1, #2) AND IMPLANT OF XENMATRIX AB (DEVICE #3, #4). PER OPERATIVE NOTES, ¿IN THE RIGHT INGUINAL AREA, THERE WAS AN ABSCESS CAVITY. ADDITIONAL PURULENT FLUID WAS DRAINED, AND THERE WAS FOUND TO BE A CAVITY WHICH HAD THE MESH IN PLACE, AND THE MESH (DEVICE #1) ON THE RIGHT SIDE WAS REMOVED COMPLETELY. THERE WAS ALSO AN INDIRECT HERNIA SAC REDUCED THROUGH THE INTERNAL RING. A XENMATRIX AB

  Patient problems: Abscess; Hematoma; Hernia; Purulent Discharge; Unspecified Infection

  MAUDE report 21888053 ↗
• InjuryMar 6, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT¿S ATTORNEY: (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH SYMPTOMATIC LEFT INCARCERATED INDIRECT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF MODIFIED KUGEL PATCH (DEVICE #1). PER OPERATIVE NOTES, ¿INDIRECT SAC WAS SEPARATED FROM CORD. HERNIA SAC CONTAIN INCARCERATED OMENTUM WAS REDUCED INTO THE PERITONEAL CAVITY. THE MODIFIED KUGEL PATCH (DEVICE #1) WAS PLACED EXTRAPERITONEALLY COVERING DIRECT, INDIRECT AND FEMORAL SPACES, AND ATTACHED TO THE PERIOSTEUM OF COOPER LIGAMENT WITH A SINGLE SUTURE.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH SYMPTOMATIC RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF 3DMAX MESH (DEVICE #2). PER OPERATIVE NOTES, ¿ADHESIONS ARE TAKEN DOWN. HERNIA FILLED WITH FAT WAS REMOVED. THE PREVIOUSLY PLACED MESH (DEVICE #1) HAD MIGRATED INFERIORLY. THE 3DMAX MESH (DEVICE #2) FOR A LEFT INGUINAL HERNIA WAS PLACED INTO THE EXTRAPERITONEAL SPACE OVER PUBIC TUBERCLE AND TACKED.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH SYMPTOMATIC RECURRENT INCARCERATED LEFT INDIRECT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE #3). PER OPERATIVE NOTES,

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

  MAUDE report 21533453 ↗
• InjuryNov 13, 2024Defective Device; Material Deformation; Patient Device Interaction Problem; Defective Device; Material Deformation; Patient Device Interaction Problem

  PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF TWO 3DMAX MESH (DEVICE#1 & DEVICE #2). PER OPERATIVE NOTES, ¿THE LEFT INDIRECT HERNIA WAS IDENTIFIED AND DISSECTED FREE FROM THE CORD STRUCTURES, AND IT WAS COMPLETELY REMOVED. A SIMILAR PROCEDURE WAS PERFORMED IN THE RIGHT PREPERITONEAL SPACE. AND THE INDIRECT HERNIA SAC WAS IDENTIFIED AND EASILY DISSECTED. A 3DMAX MESH (DEVICE#1) WAS PLACED IN THE RIGHT SIDE ANCHORED TO THE PUBIC TUBERCLE USING TACKS. A LEFT SIDED 3DMAX MESH (DEVICE#2) WAS PLACED IN THE SIMILAR FASHION AND TACKED IN A SIMILAR FASHION.¿ ON (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH CHRONIC RIGHT GROIN PAIN THEREBY UNDERWENT LAPAROSCOPIC RESECTION OF RIGHT ILIOINGUINAL NERVE. (BOTH PRIOR LAPAROSCOPIC HERNIA REPAIRS WERE WELL VISUALIZED AND WELL INTACT, WITHOUT EVIDENCE OF RECURRENT HERNIATION) ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT ROBOTIC-ASSISTED DIAGNOSTIC LAPAROSCOPY WITH EXPLANT OF BOTH 3DMAX MESH (DEVICE #1 AND DEVICE #2). PER OPERATIVE NOTES, ¿THERE WAS SOME BOLD 3DMAX MESH IN THE RIGHT ABDOMINAL REG

  Patient problems: Abdominal Pain; Hernia

  MAUDE report 20671921 ↗
• MalfunctionJun 25, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING A LAPAROSCOPIC HERNIA REPAIR, A BREAK WAS NOTED IN THE EDGE OF THE 3DMAX MESH WHILE REMOVING FROM THE PACKAGE. ANOTHER PIECE OF THE 3DMAX MESH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19607453 ↗
• InjuryApr 29, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ATTORNEY ALLEGES MULTIPLE PATIENTS HE REPRESENTS HAVE EXPERIENCE UNSPECIFIED INJURY AND ALLEGE THEY MAY HAVE REQUIRED ADDITIONAL MEDICAL/SURGICAL TREATMENT. ATTORNEY ALLEGES THIS PATIENT WAS TREATED WITH A 3DMAX MESH. CASE-SPECIFIC DETAILS NOT PROVIDED. ADDENDUM 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; Insufficient Information

  MAUDE report 19202081 ↗
• InjuryApr 29, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ATTORNEY ALLEGES MULTIPLE PATIENTS HE REPRESENTS HAVE EXPERIENCE UNSPECIFIED INJURY AND ALLEGE THEY MAY HAVE REQUIRED ADDITIONAL MEDICAL/SURGICAL TREATMENT. ATTORNEY ALLEGES THIS PATIENT WAS TREATED WITH 3DMAX. CASE-SPECIFIC DETAILS NOT PROVIDED.

  Patient problems: Abdominal Pain; Insufficient Information

  MAUDE report 19201893 ↗