Surgipro SPMM-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521101395), received between May 7, 2018 and Aug 18, 2022 — classified as 7 injuries.

The most frequently reported specific device problem is “Mechanics Altered” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2022Mechanics 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 AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, DISCOMFORT, INFLAMMATION, RECURRENCE, SCARRING, IMPAIRMENT, MENTAL PAIN, DISABILITY, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE DEVICE, SUFFERING, AND MESH FAILURE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Discomfort; Emotional Changes; Hernia; Inflammation; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 15254521 ↗
• InjuryFeb 5, 2021Adverse 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 OPEN THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, BOWEL OBSTRUCTION, BOWEL INVOLVEMENT, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

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

  MAUDE report 11286332 ↗
• InjuryFeb 5, 2021Adverse 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 OPEN THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, BOWEL OBSTRUCTION, BOWEL INVOLVEMENT, AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

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

  MAUDE report 11284982 ↗
• InjuryJul 13, 2020Adverse 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 VENTRAL HERNIA AND UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, AND MESH REMOVAL.

  Patient problems: Adhesion(s); Hernia; Injury

  MAUDE report 10268010 ↗
• InjuryJul 8, 2020Adverse 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED PAIN AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH MESH.

  Patient problems: Distress; Hernia; Injury; Pain; Unspecified Tissue Injury

  MAUDE report 10248144 ↗
• InjuryJul 7, 2019Loss of or Failure to Bond; Migration or Expulsion of Device; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Migration or Expulsion of Device; 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 MESH DETACHMENT, 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 ADDITIONAL IMPLANT AS WELL AS SURGERY TO REMOVE MESH.

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

  MAUDE report 8766065 ↗
• InjuryMay 7, 2018Adverse 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. IT WAS REPORTED THAT AFTER A VENTRAL HERNIA PROCEDURE WHERE THIS DEVICE WAS IMPLANTED, THE PATIENT EXPERIENCED SEVERE PAIN, SMALL BOWEL OBSTRUCTION, ADHESIONS, AND RECURRENCE. AFTER THE ORIGINAL PROCEDURE, ADDITIONAL POTENTIALLY RELATED PROCEDURES WERE PERFORMED, INCLUDING RECURRENCE AND REVISION.

  Patient problems: Abdominal Distention; Adhesion(s); Dyspnea; Fistula; Hernia; Inflammation; Injury; No Code Available; Obstruction/Occlusion; Pain; Perforation; Seroma; Unspecified Infection; Unspecified Tissue Injury; Vomiting

  MAUDE report 7492788 ↗

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