Fortiva™ Porcine Dermis PD2025Recalls & reported problems
Tutogen Medical GmbH · Fortiva™ porcine dermis is an extracellular collagen matrix comprised of porcine dermal tissue that has been processed and terminally sterilized via gamma irradiation. The surgical mesh device is designed to perform as a scaffold that allows for neovascularization and permits replacement of the device with patient’s tissue. The sterile device is supplied pre-hydrated in water and is provided in various sizes. The device is ready for immediate use without extra preparation (i.e., no rinsing, no s · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04041543312065), received between Nov 3, 2017 and Nov 21, 2018 — classified as 2 injuries.
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
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Hernia2
- Abdominal Pain1
- Seroma1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RTI SURGICAL, INC (RTI) RECEIVED A COMPLAINT NOTIFICATION ON (B)(4) 2018 INDICATING THAT A PATIENT UNDERWENT HERNIA REPAIR WITH IMPLANTATION OF A FORTIVA PORCINE DERMIS GRAFT (PATIENT ENROLLED IN A (B)(6) CLINICAL STUDY) ON (B)(6) 2017. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT ON (B)(6) 2018 WITH LEFT LOWER QUADRANT PAIN AND SHORTNESS OF BREATH. A CT SCAN OF THE ABDOMEN/PELVIS SHOWED A RUPTURED SIGMOID DIVERTICULUM. PATIENT WAS ADMITTED TO THE HOSPITAL WITH DIVERTICULITIS FOR ANTIBIOTIC THERAPY AND PAIN CONTROL. SHE WAS TREATED WITH ERTAPENEM, CIPRO AND FLAGYL. TO DATE, RTI HAS NOT RECEIVED ANY ADDITIONAL INFORMATION.
Patient problems: Abdominal Pain; Hernia; Unspecified Infection
MAUDE report 8094910 ↗InjuryNov 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RTI SURGICAL, INC (RTI) RECEIVED A COMPLAINT NOTIFICATION ON (B)(4) 2017 INDICATING THAT A PATIENT UNDERWENT IMPLANTATION OF A FORTIVA PORCINE DERMIS AT AN UNKNOWN DATE, AS PART OF A HERNIA REPAIR CLINICAL STUDY. ON (B)(6) 2017, THE PATIENT DEVELOPED A SEROMA (UNKNOWN LOCATION). TO DATE, RTI HAS NOT RECEIVED ANY ADDITIONAL INFORMATION.
Patient problems: Hernia; Seroma
MAUDE report 6999293 ↗
Other Mesh, surgical devices
- MEDPOR TITAN 81032Stryker Leibinger GmbH & Co. KG · Mesh, surgical1 recall1 report
- Peri-Guard PC1016NSynovis Life Technologies, Inc. · Mesh, surgical1 recall1 report
- SurgiMend® 606-200-020Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-005-001Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-300-008Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-200-016Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-300-021Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-206-007Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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