3DMAX 0117322Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741031076), received between May 30, 2019 and May 26, 2023 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, PATIENT UNDERWENT A ROBOTIC ASSISTED RIGHT INGUINAL HERNIA REPAIR WITH IMPLANT OF A 3DMAX LIGHT XL MESH ON (B)(6) 2023. AS REPORTED, 2 WEEKS LATER PATIENT DEVELOPED SYSTEMIC ITCHING FOLLOWED BY RADIATING HEAT. ABOUT 4 DAYS LATER PATIENT DEVELOPED A RASH ALL OVER HER ABDOMEN, LEGS AND ARMS. IT WAS REPORTED THAT THE PATIENT UNDERWENT REACTIVITY TEST FOR MESH FROM (B)(6) 2023 TO (B)(6) 2023. THE RESULTS WERE NEGATIVE FOR ANY REACTION TO THE 3DMAX LIGHT MESH.

  Patient problems: Hot Flashes/Flushes; Itching Sensation; Rash

  MAUDE report 17009842 ↗
• MalfunctionFeb 21, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, A 3DMAX LIGHT MESH WAS BEING USED DURING A LAPAROSCOPIC PROCEDURE. IT IS REPORTED THAT INTRAOPERATIVELY, IT BECAME APPARENT THAT THERE WAS A WEAK POINT IN THE MESH, AND THIS LED TO A HOLE WHEN TRYING TO INSERT IT THROUGH THE TROCAR. IT WAS REPORTED THAT ANOTHER 3DMAX LIGHT MESH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16414305 ↗
• MalfunctionJan 3, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING A BILATERAL LAPAROSCOPIC INGUINAL SURGERY ON 12-DEC-2022, WHILE FOLDING THE RIGHT-SIDED 3DMAX LIGHT MESH IN PREPARATION FOR INSERTION, MULTIPLE EDGES OF THE MESH TORE. IT WAS REPORTED THAT ANOTHER 3DMAX LIGHT MESH WAS USED TO COMPLETE THE RIGHT SIDED REPAIR. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16091520 ↗
• InjuryJul 15, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING A BILATERAL INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2022, TWO 3DMAX LIGHT MESH DEVICES WERE IMPLANTED ONE IN THE LEFT AND ONE IN THE RIGHT GROIN REGION. AS REPORTED, ABOUT TWO MONTHS POST IMPLANT THE PATIENT REPORTED RIGHT SIDED PAIN AND WAS DIAGNOSED WITH A SEROMA ON THE RIGHT SIDE. A DRAIN WAS PLACED AND THE FLUID WAS CULTURED WHICH WAS POSITIVE FOR A STAPHYLOCOCCUS INFECTION. ON (B)(6) 2022, THE PATIENT UNDERWENT ADDITIONAL SURGERY DURING WHICH THE 3DMAX LIGHT MESH ON RIGHT SIDE WAS REMOVED AND REPLACED WITH PHASIX MESH. AS REPORTED, THE EXPLANTED MESH WAS NOTED TO BE INCORPORATED AND NO SIGNS OF MESH INFECTION.

  Patient problems: Bacterial Infection; Pain; Seroma

  MAUDE report 15031234 ↗
• InjuryMay 24, 2022Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL 3DMAX ON (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE 3DMAX. 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: Insufficient Information; Pain

  MAUDE report 14490012 ↗
• InjuryMar 24, 2022Defective 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) 2018. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST 3DMAX MESH. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Insufficient Information; Seroma

  MAUDE report 13884436 ↗
• InjuryFeb 22, 2022Defective 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 LIGHT MESH ON (B)(6) 2018. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE 3DMAX LIGHT MESH. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. ATTORNEY ALLEGES THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 13575432 ↗
• InjuryJan 25, 2022Defective 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) 2014. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE 3DMAX MESH. 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: Hernia; Insufficient Information; Pain

  MAUDE report 13341583 ↗
• InjurySep 23, 2020Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL 3DMAX LIGHT MESH (X2) ON (B)(6) 2018 AND BARD MESH (BARD FLAT MESH) ON (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST 3DMAX LIGHT MESH (X2). 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: Hernia; Injury; Seroma

  MAUDE report 10574950 ↗
• InjuryApr 7, 2020Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF TWO UNSPECIFIED BARD/DAVOL 3DMAX LIGHT MESHES ON (B)(6) 2011. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH THE DEVICES. 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: Disability; Injury; Pain

  MAUDE report 9933241 ↗
• InjuryMay 30, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT LAPAROSCOPIC BILATERAL INGUINAL HERNIA REPAIR AND WAS IMPLANTED WITH ONE LEFT 3DMAX LIGHT MESH (DEVICE 1) AND ONE RIGHT 3DMAX LIGHT MESH (DEVICE 2). AS REPORTED APPROXIMATELY ONE MONTH POSTOPERATIVE THE PATIENT PRESENTED WITH PAIN ON THE LEFT AND RIGHT SIDE. AS REPORTED ON (B)(6) 2019 CULTURES WHERE TAKEN OF THE LEFT AND RIGHT HERNIA SAC WITH A POSITIVE FOR BACTERIA (PEPTONOPHILUS HAREI) GROWTH ON THE LEFT SIDE. ON (B)(6) 2019 THE PATIENT UNDERWENT AN OPEN SURGICAL PROCEDURE WITH REMOVAL OF THE HERNIA SACS AND BOTH OF THE 3DMAX LIGHT MESH (DEVICE 1 AND 2). THERE WAS POSITIVE BACTERIOLOGY ON BOTH HERNIA SACS. THE EXPLANTED SAMPLES WERE DISCARDED BY THE USER FACILITY. FOLLOWING EXPLANT THE PATIENT WAS MONITORED AND TREATED WITH ANTIBIOTIC FOR ONE MONTH.

  Patient problems: Bacterial Infection; Pain; Unspecified Infection

  MAUDE report 8653977 ↗