Symbotex SYM12Recalls & reported problems

Summary

The FDA's MAUDE database contains 383 adverse event reports that list this exact device (DI 10884521190344), received between Sep 15, 2017 and Sep 22, 2026 — classified as 3 deaths, 373 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (191 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 383 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  The patient's attorney alleged a deficiency against the device. The product was used for therapeutic treatment of a ventral hernia. It was reported that after implant, the patient experienced adhesions, recurrence, pain and suffering. Post-operative patient treatment included removal of mesh and hernia repair with new mesh.

  Patient problems: Adhesion(s); Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 50858883 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25332751 ↗
• DeathMay 26, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, PAIN, SUFFERING, BULGE OF HERNIA IN ABDOMEN, EMOTIONAL DISTRESS, RECURRENCE, AND DEATH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION AND HERNIA REPAIR WITH MESH. INFORMATION RECEIVED INDICATES THE PATIENT IS DECEASED. NO INFORMATION WAS PROVIDED REGARDING THE CIRCUMSTANCES OF EXPIRATION.

  Patient problems: Abdominal Distention; Adhesion(s); Distress; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 25280890 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INCISIONAL UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25151086 ↗
• MalfunctionApr 27, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT, FOLLOWING SURGERY IN WHICH THE IMPLANTABLE PROSTHESIS WAS PLACED FOR WHITE LINE HERNIATION REPAIR, THE PATIENT EXPERIENCED A REDUCED ABILITY TO EAT (A SIMPLE MEAL FELT ¿TOO MUCH,¿ AS IF THE STOMACH HAD SHRUNK), ABNORMAL FATIGUE, TIGHTNESS IN THE PROSTHESIS, ELECTRIC SHOCK SENSATIONS, THROBBING PAIN IN THE URINARY TRACT, AND DIZZINESS.

  Patient problems: Dizziness; Fatigue; Neuropathy

  MAUDE report 25000850 ↗
• InjuryApr 14, 2026Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN UMBILICAL AND INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, OBSTRUCTION, PERFORATION, RECURRENCE, MESH MIGRATION, PAIN, SUFFERING, MENTAL ANGUISH AND EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED HOSPITALIZATION, REVISION SURGERY, HERNIA REPAIR WITH NEW MESH AND MESH REMOVAL.

  Patient problems: Adhesion(s); Distress; Emotional Changes; Hernia; Obstruction/Occlusion; Pain; Perforation; Unspecified Tissue Injury

  MAUDE report 24874834 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH.

  Patient problems: Hernia; Unspecified Tissue Injury

  MAUDE report 24546685 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR LAPAROSCOPIC THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24485658 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT GASTRIC BYPASS, SLEEVE GASTRECTOMY, HYSTERECTOMY, COLECTOCYSTECTOMY, UMBILICAL HERNIA, AND BODY LIFT BETWEEN 2016 AND TODAY. IN (B)(6) 2019, THE PATIENT UNDERWENT UMBILICAL HERNIA PROCEDURE. SINCE 2020, THE PATIENT HAS BEEN EXPERIENCING JOINT PAIN. MULTIPLE INJECTIONS FOR TENDINITIS AND OSTEOARTHRITIS AND SHOULDER SURGERIES, BUT THE MOST SIGNIFICANT AND NEARLY UNBEARABLE PAIN REMAINS UNEXPLAINED ABDOMINAL PAIN, DESPITE SEVERAL EXAMINATIONS.

  Patient problems: Abdominal Pain; Arthropathy; Unspecified Musculoskeletal problem

  MAUDE report 24414070 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER THE PATIENT UNDERWENT PARIETAL SURGERY WITH PLACEMENT OF A 10X15 CM IMPLANT OF A SURGICAL MESH ON (B)(6) 2023, FOR REPAIR OF A 4 MM UMBILICAL HERNIA. IMMEDIATELY UPON POSTOPERATIVE AWAKENING, THE PATIENT EXPERIENCED SEVERE ABDOMINAL PAIN, WHICH HAS PERSISTED CONTINUOUSLY FOR OVER TWO YEARS. THE EVENT RESULTED IN PERMANENT, INTOLERABLE PAIN WITH SIGNIFICANT FUNCTIONAL IMPAIRMENT, INCLUDING PROFOUND PHYSICAL EXHAUSTION, INABILITY TO ENGAGE IN SPORTS OR PHYSICAL ACTIVITY, LOSS OF SOCIAL FUNCTIONING, AND MARKED LIMITATION OF ACTIVITIES OF DAILY LIVING. THE ADVERSE EVENT HAS CAUSED A SUBSTANTIAL DECLINE IN QUALITY OF LIFE AND PSYCHOLOGICAL WELL-BEING AND HAS SIGNIFICANTLY IMPAIRED THE PATIENT¿S ABILITY TO WORK; ALTHOUGH FULL-TIME WORK WAS RESUMED, THIS REQUIRED EXTREME ADAPTATION AND IS ASSOCIATED WITH SEVERE PAIN UPON WAKING, DURING WORK, AND AFTER RETURNING HOME, NECESSITATING IMMEDIATE REST. MEDICAL MANAGEMENT INCLUDES TWICE-WEEKLY PHYSIOTHERAPY, TWICE-MONTHLY OSTEOPATHY, WITH REPEATED EVALUATIONS, AND FOLLOW-UP AT A HOSPITAL-BASED CHRONIC PAIN UNIT. DESPITE THESE INTERVENTIONS, PAIN RELIEF REMAINS TEMPORARY AND INSUFFICIENT, WITH PERSISTENT, DEBILITATING SY

  Patient problems: Extreme Exhaustion; Pain

  MAUDE report 24171107 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 23612531 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN AND RECURRENCE.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 23393353 ↗
• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DEFECTIVE MESH, DISCOMFORT, INFLAMMATION, ADHESIONS, SCARRING, PAIN, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, MENTAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Discomfort; Emotional Changes; Inflammation; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 23382993 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, DIASTASIS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Adhesion(s); Hernia; Muscle Weakness/Atrophy; Pain; Unspecified Tissue Injury

  MAUDE report 23367924 ↗
• InjuryOct 1, 2025Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Distress; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 23196539 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abscess; Distress; Inflammation; Necrosis; Pain; Purulent Discharge; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 23099194 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Material Split, Cut or Torn; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Material Split, Cut or Torn

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A RECURRENT VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ADHESIONS, MESH EROSION, MESH RUPTURED IN THE MIDDLE, MESH FAILURE AND DIFFICULTY MOVING BOWELS.

  Patient problems: Adhesion(s); Erosion; Hernia; Pain; Unspecified Gastrointestinal Problem; Unspecified Tissue Injury

  MAUDE report 23097826 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT; THE PATIENT EXPERIENCED EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Discomfort; Distress; Emotional Changes; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 22906113 ↗
• InjuryAug 22, 2025Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Hernia; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 22874125 ↗
• InjuryAug 14, 2025Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH MIGRATION, MESH ENCAPSULATION, LACK OF ADEQUATE INGROWTH, ABSCESS, PAIN, RECURRENCE, BOWEL OBSTRUCTION, SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Abscess; Foreign Body Reaction; Hernia; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 22809143 ↗
• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED INTERVENTION SURGERY AND MEDICATION.

  Patient problems: Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 22754601 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A LEFT FLANK HERNIA AND A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, SEROMA, INCARCERATION, CHRONIC INFLAMMATION, FOREIGN BODY GIANT CELLS, AND HARDNESS AROUND SURGERY SITE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REMOVAL SURGERY, AND HERNIA REPAIR WITH NEW MESH, AND MEDICATION.

  Patient problems: Abdominal Distention; Foreign Body Reaction; Hernia; Inflammation; Pain; Seroma; Unspecified Tissue Injury

  MAUDE report 22549460 ↗
• InjuryJul 17, 2025Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH AND MEDICATION.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 22538692 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Adhesion(s); Distress; Obstruction/Occlusion; Pain; Perforation; Unspecified Tissue Injury

  MAUDE report 22395466 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, INFECTION, RECURRENCE, ADHESIONS, OBSTRUCTION, SEROMA, ERYTHEMA, CELLULITIS, PUS WITHIN MIDLINE NODULE, LYMPHEDEMA, CHRONIC BILATERAL LEG PAIN, REDUCED MOBILITY, AND FATIGUE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH, MEDICATION, REHABILITATION AND PHYSICAL THERAPY.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cellulitis; Erythema; Fatigue; Hernia; Nodule; Obstruction/Occlusion; Pain; Purulent Discharge; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 22236916 ↗