3DMAX 0117311Recalls & reported problems

Summary

The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 00801741031038), received between Aug 4, 2016 and Aug 26, 2026 — classified as 47 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (29 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 95 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Tear, Rip or Hole in Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50456679 ↗
• InjuryJul 28, 2026Patient-Device Incompatibility

  Per information provided:(b)(6) 2012 - Patient was diagnosed with bilateral inguinal hernias and an umbilical hernia thereby underwent laparoscopic repair of bilateral inguinal hernias with the implant of two 3DMax Light meshes (Device 1 - right and 2 - left) and open umbilical hernia repair with the implant of Ventralex ST Hernia Patch (Device 3). Per op notes, "Two 3DMax Light meshes (Device 1 - right and 2 - left) were placed bilaterally using tacks. Next, the umbilical defect was identified. A small Ventralex ST Hernia Patch (Device 3) was placed in the peritoneal cavity using prolene sutures." (b)(6) 2014 - Patient was diagnosed with recurrent bilateral inguinal hernias thereby underwent robotic-assisted laparoscopic repair of recurrent right inguinal hernia with the removal of mesh (Device 1) and implant of PerFix Plug (Device 4), open repair of left inguinal hernia with the implant of PerFix Plug (Device 5). Per op notes, "Omental adhesions were taken down on both left and right mid abdomen. Explored on the right side, the mesh (Device 1) was dissected off the anterior abdominal wall. Then a medium PerFix Plug (Device 4) was placed into the abdominal cavity. Attention was th

  Patient problems: Adhesion(s); Hernia

  MAUDE report 50050311 ↗
• InjuryJul 9, 2026Adverse Event Without Identified Device or Use Problem

  PER JOURNAL ARTICLE: "COMPARISON OF SINGLE-INCISION TOTALLY EXTRAPERITONEAL REPAIR OF INGUINAL HERNIA AND CONVENTIONAL MULTI-PORT TOTALLY EXTRAPERITONEAL REPAIR: A RETROSPECTIVE STUDY". THIS RETROSPECTIVE SINGLE-CENTER STUDY EVALUATED THE FEASIBILITY, SAFETY, AND CLINICAL OUTCOMES OF SINGLE-INCISION TOTALLY EXTRAPERITONEAL REPAIR (SILS-TEP) COMPARED WITH CONVENTIONAL THREE-PORT TEP REPAIR FOR INGUINAL HERNIA TREATMENT. A TOTAL OF 102 PATIENTS WHO UNDERWENT TEP REPAIR BETWEEN (B)(6) 2022 AND (B)(6) 2025 WERE INCLUDED. THE STUDY ASSESSED OPERATIVE TIME, POSTOPERATIVE PAIN, COMPLICATIONS, CHRONIC PAIN, RECURRENCE, AND HOSPITALIZATION OUTCOMES. THE STUDY INCLUDED 102 PATIENTS (62 PATIENTS UNDERWENT SILS-TEP AND 40 PATIENTS UNDERWENT CONVENTIONAL THREE-PORT TEP). THE MEAN AGE WAS 66 YEARS IN THE SILS-TEP GROUP AND 68 YEARS IN THE THREE-PORT TEP GROUP. MOST PATIENTS WERE MALE (87% AND 93%, RESPECTIVELY). BOTH GROUPS HAD COMPARABLE BASELINE CHARACTERISTICS AND HERNIA CLASSIFICATIONS. ALL PATIENTS UNDERWENT LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEP) INGUINAL HERNIA REPAIR UNDER GENERAL ANESTHESIA. SITE INCLUDED UNILATERAL AND BILATERAL. IN THE SILS-TEP GROUP, SURGERY WAS PERFORMED THROUGH

  Patient problems: Hematoma; Seroma

  MAUDE report 25758013 ↗
• InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem

  PER JOURNAL ARTICLE: "ANALYSIS OF LEARNING CURVE OF LAPAROSCOPIC TRANS ABDOMINAL PREPERITONEAL (TAPP) INGUINAL HERNIA REPAIR". THIS RETROSPECTIVE STUDY EVALUATES LAPAROSCOPIC TRANSABDOMINAL PREPERITONEAL (TAPP) INGUINAL HERNIA REPAIR PERFORMED BY SINGLE SURGEON IN 55 PATIENTS (53 MALES AND 2 FEMALES). THE STUDY INCLUDED A TOTAL OF 79 REPAIRS, INCLUDING 31 UNILATERAL AND 24 BILATERAL CASES BETWEEN JULY 2018 AND JANUARY 2020. HERNIA TYPES INCLUDED DIRECT (N=50), INDIRECT (N=23), AND COMBINED (N=6), WITH SOME RECURRENT CASES (N=3). A BARD 3DMAX LIGHT POLYPROPYLENE MESH (10 X 16 CM) WAS USED IN ALL CASES, POSITIONED WITH ADEQUATE OVERLAP AND FIXED USING A SINGLE TACK AT COOPER'S LIGAMENT, FOLLOWED BY PERITONEAL CLOSURE WITH 3-0 PROLENE. POSTOPERATIVELY, COMPLICATIONS INCLUDED SEROMA (N=7) PARTICULARLY IN PATIENTS WITH LARGE HERNIA SACS. TWO PATIENTS (N=2) DEVELOPED NEUROPATHY. ONE PATIENT COMPLAINED OF CHRONIC PRICKING TYPE OF INGUINAL PAIN, WHILE THE OTHER DEVELOPED NUMBNESS OVER THE LATERAL ASPECT OF GROIN AND THIGH (MERALGIA). THERE WAS ONE MEDIAL RECURRENCE (N=1) NOTED DURING THE FOLLOW UP PERIOD IN A PATIENT WHO HAD A LARGE HERNIAL SAC WITH BOTH DIRECT AND INDIRECT COMPONENTS. THE

  Patient problems: Hernia; Neuropathy; Seroma

  MAUDE report 25753647 ↗
• InjuryMay 21, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2016 PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA, THEREBY UNDERWENT REPAIR WITH IMPLANT OF 3DMAX LIGHT MESHES (DEVICE 1 AND 2). (NOTE: THERE IS NO OPERATIVE NOTES PROVIDED FOR THIS PROCEDURE). ATTORNEY ALLEGES PATIENT HAD INFECTION, HERNIA RECURRENCE, ADHESION, PAIN.

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

  MAUDE report 25240548 ↗
• MalfunctionMay 11, 2026Material Split, Cut or Torn

  AS REPORTED, DURING AN INGUINAL HERNIA REPAIR PROCEDURE USING A 3DMAX LIGHT MESH, THE SURGEON OBSERVED A TEAR IN THE MESH UPON OPENING THE PACKAGE. THE PROCEDURE WAS COMPLETED USING ANOTHER 3DMAX LIGHT MESH. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25133869 ↗
• MalfunctionMay 7, 2026Material Split, Cut or Torn

  AS REPORTED, DURING A TAPP PROCEDURE ON (B)(6) 2026, THE SURGEON INSERTED THE 3DMAX LIGHT MESH THROUGH A 12 MM TROCAR. UPON VISUALIZATION, A TEAR WAS OBSERVED IN THE UPPER PORTION OF THE MESH. THE MESH WAS REMOVED, AND A NEW MESH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25116910 ↗
• MalfunctionMay 6, 2026Device Contamination with Chemical or Other Material

  AS REPORTED, DURING A ROUTINE INSPECTION AFTER RECEIVING THE GOODS, UNKNOWN DARK, THREAD-LIKE SUBSTANCES WERE IDENTIFIED INSIDE THE TRANSPARENT INNER PACKAGING OF THREE PATCHES (3DMAX LIGHT MESH). THERE WAS NO DAMAGE OBSERVED TO THE PACKAGE, AND IT WAS COMPLETELY SEALED BEFORE OPENING. THIS FILE REPRESENTS DEVICE #2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25093769 ↗
• MalfunctionMay 6, 2026Device Contamination with Chemical or Other Material

  AS REPORTED, DURING A ROUTINE INSPECTION AFTER RECEIVING THE GOODS, UNKNOWN DARK, THREAD-LIKE SUBSTANCES WERE IDENTIFIED INSIDE THE TRANSPARENT INNER PACKAGING OF THREE PATCHES (3DMAX LIGHT MESH). THERE WAS NO DAMAGE OBSERVED TO THE PACKAGE, AND IT WAS COMPLETELY SEALED BEFORE OPENING. THIS FILE REPRESENTS DEVICE #1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25093767 ↗
• InjuryApr 7, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2015- PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX LIGHT MESHES (DEVICE 1 AND 2). PER OP NOTES, ¿INDIRECT HERNIA SAC WAS IDENTIFIED IN THE RIGHT AND LEFT INGUINAL REGION AND WERE DISSECTED. A 3DMAX LIGHT MESHES (DEVICE 1 AND 2) WERE PLACED IN THE RIGHT AND LEFT POSITION WITH ADEQUATE MEDIAL OVERLAP COVERING FROM BILATERAL MYOPECTINEAL ORIFICES AND TACKED¿. (B)(6) 2017- PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA, RIGHT GROIN PAIN, LEFT INGUINAL PAIN, ABDOMINAL PAIN, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EXPLANT OF 3DMAX LIGHT MESH (DEVICE 1) AND IMPLANT OF SYNTHETIC MESH. PER OP NOTES, ¿A SMALL RIGHT INDIRECT INGUINAL HERNIA WAS IDENTIFIED UNDERNEATH THE MESH (DEVICE 1). THERE WAS NO RECURRENT HERNIA OR ADHESIONS ON THE LEFT SIDE. THE MESH IN THE RIGHT SIDE (3DMAX LIGHT MESH-DEVICE 1) WAS DISSECTED. A SYNTHETIC MESH WAS PLACED INTO RIGHT PREPERITONEAL SPACE AND TACKED¿. (B)(6) 2018- PATIENT WAS DIAGNOSED WITH LEFT INGUINAL GROIN PAIN, THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR. PER OP NOTES, ¿MINIMAL ADHESIONS WERE NOTED ON THE RIGHT GROIN REGION AND

  Patient problems: Abdominal Pain

  MAUDE report 24797035 ↗
• InjuryApr 1, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2019 ¿ PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA, RECURRENT LEFT INGUINAL HERNIA AND UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF 3DMAX LIGHT MESH (RIGHT - DEVICE 1, LEFT - DEVICE 2). PER OP NOTES, ¿RIGHT SIDE WAS DISSECTED. A MEDIUM 3DMAX MESH (DEVICE 1) WAS PLACED INTO THE PREPERITONEAL SPACE AND ATTACHED WITH TACKS OVER COOPER'S LIGAMENT TO LATERAL SIDEWALL AND ANTERIORLY. THE LEFT RECURRENT SIDE WAS APPROACHED. A LATERAL RECURRENCE WAS FOUND. A LARGE 3DMAX MESH (DEVICE 2) WAS PLACED IN THE PREPERITONEAL SPACE AND TACKED TO COOPER LIGAMENT AND ADDITIONALLY TACKED TO RIGHT MEDIAL MESH. UMBILICAL HERNIA WAS DISSECTED. UMBILICAL PLASTY WAS PERFORMED WITH SUTURES.¿ ATTORNEY ALLEGES ABDOMINAL PAIN, TESTICULAR PAIN AND ECCHYMOSIS AND SWELLING OF TESTICLES.

  Patient problems: Abdominal Pain

  MAUDE report 24756574 ↗
• InjuryMar 26, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA AND RIGHT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX LIGHT (DEVICE 2 AND 3). PER OP NOTES, ¿AN INCISION WAS MADE IN THE INFRAUMBILICAL REGION TOWARDS THE LEFT SIDE. AN INDIRECT HERNIA WAS IDENTIFIED AND REDUCED. THE OMENTUM WAS STUCK WITH A MASS EFFECT INTO THE INDIRECT SPACE AND STARTED PULLING ON THE HERNIA SAC TO REDUCE IT. THE COLON WAS HERNIATED THROUGH THE INTERNAL RING AND WAS INCARCERATED THERE AND REDUCED THE HERNIA AND REMOVED THE COLON FROM THE INTERNAL RING AND THEN REDUCED THE HERNIA SAC COMPLETELY. NO EVIDENCE OF HERNIA WAS NOTED IN DIRECT SPACE. A 3DMAX LIGHT (DEVICE 2) WAS PLACED INTO THE PREPERITONEAL SPACE AND TO COVER THE DIRECT, INDIRECT AND FEMORAL SPACE AND SECURED WITH A TACKING DEVICE. A LARGE RIGHT 3DMAX LIGHT (DEVICE 3) WAS PLACED INTO THE PRE-ABDOMINAL CAVITY AND SECURED WITH A TACKING DEVICE.¿ ATTORNEY ALLEGES HERNIA RECURRENCE, PAIN AND SUFFERING.

  Patient problems: Hernia; Pain

  MAUDE report 24703326 ↗
• MalfunctionMar 19, 2026Patient-Device Incompatibility

  AS PER ANSM (N° R2606566): (B)(6) 2025 PATIENT WAS IMPLANTED WITH A 3DMAX LIGHT MESH. DATE OF OCCURRENCE: (B)(6) 2026. DESCRIPTION OF INCIDENT: LAPAROSCOPIC REPAIR OF LEFT INGUINAL HERNIA. AS PER THE SURGICAL REPORT OF (B)(6) 2025: DIAGNOSIS: SYMPTOMATIC LEFT INGUINAL HERNIA NATURE OF THE PROCEDURE: RADICAL REPAIR UNDER LAPAROSCOPY WITH PLACEMENT OF A PROSTHESIS VIA THE PREPERITONEAL ROUTE UNDER GENERAL ANESTHESIA. SUPINE POSITION. OROTRACHEAL INTUBATION. LAPAROSCOPY POSITION. BETADINE ANTISEPTIC. SURGICAL DRAPES IN PLACE. COMPLETE PREOPERATIVE CHECKLIST. INJECTION OF 2 G CEFAZOLIN AT INDUCTION. INCISION BELOW THE UMBILICUS. OPENING OF THE RECTUS SHEATH AND CREATION OF A PREVESICAL SPACE WITH A BALLOON. INSUFFLATION AT 12 CM OF MERCURY AFTER PLACEMENT OF A 10 MM TROCAR. EXPLORATION CONFIRMS THE PRESENCE OF AN INDIRECT HERNIA. A 5 MM TROCAR WAS PLACED ON THE MIDLINE. USING BIPOLAR FORCEPS, THE BLADDER WAS FREED BEHIND THE PUBIS, THEN THE PERITONEUM WAS FREED IN THE LEFT ILIAC FOSSA. A SECOND 5 MM TROCAR WAS PLACED UNDER VISUAL CONTROL. USING THE TWO DISSECTING FORCEPS, WE CAN RELEASE THE INDIRECT HERNIA SAC BY PEDICULATING THE VAS DEFERENS AND SPERMATIC VESSELS. THE HERNIA IS COMPLE

  Patient problems: Pain

  MAUDE report 24637504 ↗
• InjuryMar 4, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH SYMPTOMATIC LEFT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX LIGHT (DEVICE 1). PER OP NOTES, ¿AN INFERIOR UMBILICAL INCISION WAS MADE. AN INDIRECT INCARCERATED HERNIA SAC WAS IDENTIFIED AND REDUCED. A 3DMAX LIGHT (DEVICE 1) WAS PLACED IN THE PRE-PERITONEAL SPACE AND TACKED TO COOPER¿S LIGAMENT.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH LIPOMA AND SMALL LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 2). PER OP NOTES, ¿A LEFT INGUINAL INCISION WAS MADE. A SMALL WEAKNESS IN THE MEDIAL FLOOR OF THE INGUINAL CANAL WAS IDENTIFIED. A PERFIX PLUG (DEVICE 2) WAS PLACED INTO THE FLOOR AND FASCIA CLOSED OVER IT.¿ (B)(6) 2017 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED REPAIR WITH IMPLANT OF 3DMAX MESH (DEVICE 3). PER OP NOTES, ¿ADHESIONS TO THE BILATERAL INGUINAL AREAS WERE IDENTIFIED AND TAKEN DOWN. THE MESH (DEVICE 1) ALONG THE POSTERIOR AREA WAS DISSECTED AWAY FROM THE INFERIOR EPIGASTRIC VESSELS WHICH WERE COMPLETELY ADHERED TO IT. A VERY LARGE DIRECT HERNIA WAS IDENTIFIED AND REDUCED. THE MESH (DEVICE

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24505065 ↗
• MalfunctionFeb 25, 2026Device Contamination with Chemical or Other Material

  AS REPORTED, DURING ROUTINE INSPECTION AFTER RECEIVING THE GOODS, THE DISTRIBUTOR DISCOVERED UNKNOWN BLUE FILAMENTOUS SUBSTANCES INSIDE THE TRANSPARENT INNER PACKAGING OF THE PATCH. THE OUTER PACKAGING WAS INTACT, AND THE INNER PACKAGING WAS PROPERLY SEALED BEFORE OPENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444420 ↗
• InjuryFeb 23, 2026Patient-Device Incompatibility

  AS REPORTED, IN (B)(6) 2022 THE PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE AND WAS IMPLANTED WITH A 3DMAX LIGHT MESH. IT WAS REPORTED THAT SINCE THE PROCEDURE THE PATIENT HAS BEEN EXPERIENCING INFLAMMATORY SYMPTOMS, FIBROSIS AND CHRONIC ABDOMINAL/BACK PAIN.

  Patient problems: Abdominal Pain; Back pain; Fibrosis; Inflammation

  MAUDE report 24412843 ↗
• MalfunctionFeb 5, 2026Unsealed Device Packaging

  AS REPORTED, DURING A PROCEDURE IT WAS NOTICED THAT THAT THE INNER PACKAGING OF THE 3DMAX LIGHT MESH WAS NOT PROPERLY SEALED. IT WAS REPORTED THAT THE MESH WAS NOT USED, AND ANOTHER MESH WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED THE OUTER PACKAGING WAS INTACT, AND THE INNER PACKAGING WAS NOT FULLY SEALED BEFORE OPENING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24271922 ↗
• InjuryJan 29, 2026Migration

  PER INFORMATION PROVIDED: ON (B)(6) 2018: PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA AND UMBILICAL HERNIA THEREBY UNDERWENT ROBOTIC REPAIR WITH THE IMPLANT OF 3DMAX LIGHT MESHES (RIGHT ¿ DEVICE 1, LEFT ¿ DEVICE 2). PER OP NOTES, ¿A PALPABLE UMBILICAL HERNIA WAS IDENTIFIED. ON RIGHT, A LARGE DIRECT INGUINAL HERNIA WAS IDENTIFIED. A LARGE 3DMAX LIGHT MESH (DEVICE 1) WAS PLACED AND SECURED LATERALLY USING SUTURES. ON LEFT SIDE, DIRECT INGUINAL HERNIA WAS NOTED. A ANOTHER 3DMAX LIGHT MESH (DEVICE 2) WAS PLACED AND SECURED MEDIALLY IN SAME FASHION USING SUTURES.¿ ON (B)(6) 2019: PATIENT WAS DIAGNOSED WITH RECURRENT BILATERAL INGUINAL HERNIA AND UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF SYNTHETIC MESHES. PER OP NOTES, ¿THE MESH (DEVICE 1, 2) HAD BEEN ROTATED SUPERIORLY AND PATIENT HAD BILATERAL RECURRENT INGUINAL HERNIAS. THE MESH WAS WELL INCORPORATED. ON RIGHT, THE ILIOINGUINAL NERVE WAS RESECTED. A LARGE DIRECT HERNIA WAS IDENTIFIED. A SYNTHETIC MESH WAS PLACED INTO INTERNAL RING USING SUTURES. ON LEFT, THE NERVE WAS RESECTED. A SMALL DIRECT INGUINAL HERNIA WAS REPAIRED WITH SYNTHETIC MESH USING SUTURES. THE SMALL UMBILICAL HERNIA WAS DISSECTED OUT.¿

  Patient problems: Hernia; Nerve Damage

  MAUDE report 24207161 ↗
• InjuryDec 29, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 1). PER OP NOTES, ¿A DIRECT HERNIA DEFECT WAS IDENTIFIED AND EXCISED. A PERFIX PLUG (DEVICE 1) WAS PLACED AND SECURED WITH SUTURES.¿ (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA, CHRONIC LEFT INGUINODYNIA AND MESHOMA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EXCISION OF PERFIX PLUG (DEVICE 1) AND IMPLANT OF 3DMAX LIGHT (DEVICE 2). PER OP NOTES, ¿THE PRIOR MESH PLUG (DEVICE 1) WAS NOTED, RESECTED AND REMOVED. THE DIRECT HERNIA SAC WAS IDENTIFIED AND REDUCED. ILIOINGUINAL NEURECTOMY WAS PERFORMED. ADHESIONS WERE LYSED. A LARGE 3DMAX LIGHT (DEVICE 2) WAS PLACED AND TACKED.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH CHRONIC LEFT INGUINAL PAIN AND RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH NEURECTOMY AND IMPLANT OF BARD FLAT MESH (DEVICE 3). PER OP NOTES, ¿SCAR WAS EXCISED. THE GENITOFEMORAL AND ILIOINGUINAL NERVE WERE IDENTIFIED AT THE AREA OF INGUINAL CANAL. SIGNIFICANT SCARRING WAS NOTED. THESE NERVES WERE DISSECTED FREE AND NEURECTOMY WAS PERFORMED. THE HERNIA DEFECT WAS NOTED AND R

  Patient problems: Hernia; Nerve Damage; Pain; Scar Tissue

  MAUDE report 23904385 ↗
• MalfunctionDec 23, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, DURING ROUTINE INSPECTION AFTER RECEIVING THE GOODS, THE DISTRIBUTOR DISCOVERED UNKNOWN BLUE FILAMENT SUBSTANCES INSIDE THE INNER PACKAGING OF A 3DMAX MESH (DEVICE 1) AND TWO 3DMAX LIGHT MESH (DEVICE 2 & 3). IT WAS REPORTED THAT, THE OUTER PACKAGING WAS INTACT, AND THE INNER PACKAGING WAS PROPERLY SEALED BEFORE OPENING. THIS FILE REPRESENTS DEVICE 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23880414 ↗
• MalfunctionDec 23, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, DURING ROUTINE INSPECTION AFTER RECEIVING THE GOODS, THE DISTRIBUTOR DISCOVERED UNKNOWN BLUE FILAMENT SUBSTANCES INSIDE THE INNER PACKAGING OF A 3DMAX MESH (DEVICE 1) AND TWO 3DMAX LIGHT MESH (DEVICE 2 & 3). IT WAS REPORTED THAT, THE OUTER PACKAGING WAS INTACT, AND THE INNER PACKAGING WAS PROPERLY SEALED BEFORE OPENING. THIS FILE REPRESENTS DEVICE 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23880410 ↗
• MalfunctionDec 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, A LAPAROSCOPIC SURGERY WAS PERFORMED ON (B)(6) 2025. DURING THIS PROCEDURE, WHEN THE HEALTH PROFESSIONAL GRASPED THE 3DMAX LIGHT MESH "WITH FORCEPS, A HOLE OPENED UP." THE HOLE WAS NOTED PRIOR TO IMPLANTATION AND A NEW MESH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777257 ↗
• InjuryNov 21, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, ON (B)(6) 2022 THE PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE AND WAS IMPLANTED WITH A 3DMAX LIGHT MESH. IT WAS REPORTED THAT SINCE THE PROCEDURE THE PATIENT HAS BEEN EXPERIENCING SIGNIFICANT TOLERANCE/ALLERGY ISSUES, INCLUDING FIBROSIS AND A REACTION IN THE OPERATED AREA.

  Patient problems: Abdominal Pain; Back pain; Fibrosis; Hypersensitivity/Allergic reaction; Inflammation

  MAUDE report 23616299 ↗
• MalfunctionOct 8, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, ON (B)(6) 2025 THE PATIENT UNDERWENT A TENSION-FREE LAPAROSCOPIC HERNIA REPAIR. DURING THE PROCEDURE, SUSPECTED CONTAMINANTS (SMALL YELLOW STAINS OF UNKNOWN NATURE) WERE FOUND ON THE STERILE INNER PACKAGING OF THE 3DMAX LIGHT MESH. THE PRODUCT BOX WAS CONFIRMED TO BE FULLY SEALED WITH NO VISIBLE DAMAGE TO THE INNER OR OUTER PACKAGING. ANOTHER MESH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23248493 ↗
• MalfunctionOct 6, 2025Unsealed Device Packaging; Unsealed Device Packaging

  AS REPORTED, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE INNER PACKAGING OF THE 3D MAX LIGHT MESH WAS FOUND TO BE NOT SEALED PROPERLY. IT WAS REPORTED THAT ANOTHER MESH WAS USED TO COMPLETE THE PROCEDURE. THE OUTER PACKAGING WAS INTACT AND PROPERLY SEALED BEFORE OPENING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23220875 ↗