Surgipro SPM-149-WRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521101340), received between Sep 30, 2019 and Apr 22, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Mechanics Altered” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K915526); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2022Degraded; Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Degraded; Material Deformation; Mechanics Altered; 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 HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH DEGRADATION, MESH DEFORMED, MESH NOT INCORPORATED, DEFECTIVE MESH, FAILURE OF MESH, INFLAMMATION, BACTERIAL PROLIFERATION, INFECTION, BACTERIAL INFECTION, MESH ENCASED IN BIOFILM, DRAINING ABSCESS, PERFORATION, RECURRENCE, MENTAL PAIN, SCARRING, DISFIGUREMENT, PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, PARTIAL REMOVAL OF MESH, REMOVAL OF MESH, MEDICATION.

  Patient problems: Abscess; Adhesion(s); Bacterial Infection; Deformity/ Disfigurement; Distress; Emotional Changes; Fluid Discharge; Foreign Body Reaction; Hernia; Inflammation; Pain; Perforation; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 14188533 ↗
• InjuryNov 23, 2020Degraded; Degraded

  ACCORDING TO THE REPORTER, FROM A PREVIOUS SACROCOLPOPEXY, 4CM WAS EXCISED WITH FULL THICKNESS VAULT EROSION. MOST OF THE MESH WAS STILL IN THE PATIENT.

  Patient problems: Foreign Body In Patient; Unspecified Tissue Injury

  MAUDE report 10886464 ↗
• InjuryNov 18, 2020Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; 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 VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED CHRONIC ABDOMINAL PAIN, INFECTION, SEROMA, OPEN DRAINING WOUND, RECURRENCE, MENTAL PAIN, PAIN, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, FAILURE OF MESH, DISCOMFORT, INFLAMMATION, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

  Patient problems: Abdominal Distention; Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Constipation; Cramp(s) /Muscle Spasm(s); Diarrhea; Discomfort; Emotional Changes; Fistula; Fluid Discharge; Hernia; Impaired Healing; Inflammation; Obstruction/Occlusion; Pain; Seroma; Unspecified Infection; Unspecified Tissue Injury; Urinary Frequency / Polyuria; Urinary Tract Infection; Vomiting

  MAUDE report 10861056 ↗
• InjuryAug 15, 2020Degraded; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Degraded; Mechanics Altered; 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 THE IMPLANT, THE PATIENT EXPERIENCED RECURRENT HERNIA, ADHESIONS, HARDENED MESH AND ABSCESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL SURGERY.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Discomfort; Emotional Changes; Failure of Implant; Foreign Body Reaction; Hernia; Inflammation; Injury; Nausea; No Code Available; Nodule; Pain; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 10411715 ↗
• InjuryAug 4, 2020Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, A MESH WAS USED DURING A PROMONTOFIXATION (PROLAPSE CURE). THIS PROSTHESIS WAS INVOLVED IN A VAGINAL FISTULA A FEW YEARS LATER. PART OF THE PROSTHESIS AND WAS SENT TO BACTERIOLOGY. THE MESH WAS DAMAGED.

  Patient problems: Abnormal Vaginal Discharge; Fistula

  MAUDE report 10365259 ↗
• InjurySep 30, 2019Loss of or Failure to Bond; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Loss of or Failure to Bond; Mechanics Altered; 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 INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN NUMEROUS MESH INFECTIONS AND ABDOMINAL WALL INFECTIONS, MESH NON-ADHERENT, ABDOMINAL ABSCESS, DEFECTIVE DEVICE, MESH FAILURE, PAIN , MENTAL PAIN, SUFFERING, DISABILITY, PERMANENT IMPAIRMENT, ADHESIONS, DRAINAGE, DISFIGUREMENT, AND LOSS OF ENJOYMENT OF LIFE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, ABDOMINAL WALL WOUND EXPLORATION AND DEBRIDEMENT, INTERVENTIONAL RADIOLOGY-DIRECTED ABSCESS FLUID DRAINAGE, MEDICATION AND MESH REMOVAL.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Deformity/ Disfigurement; Diarrhea; Discomfort; Emotional Changes; Erythema; Fever; Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Inflammation; Injury; Necrosis; Nodule; Pain; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9137893 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K915526. One submission often covers many models, so check the product and lot details in each record.

• Z-1009-2011 · Dec 15, 2010 · Terminated
  AutoSuture SURGIPRO Polyproylene Mesh Clear 3" x 5" Sterile REF SPM 35 Surgipro Flat Sheet mesh is a non-absorbable, polypropylene surgical mesh exhibiting high burst strength