SURGIMESH®XB TINTRAC15Recalls & reported problems
Aspide Medical · A non woven, non knitted layer reinforcement material made from polypropylene and a silicone layer · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03700296902633), received between Aug 17, 2017 and Aug 17, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
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
- Device Dislodged or Dislocated1
Patient problems
- Abdominal Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 17, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON (B)(6) 2016 SURGEON #1 REPAIRED A SMALL UMBILICAL HERNIA ON THE PATIENT LAPAROSCOPICALLY USING A SURGIMESH XB TINTRA C15. THE XB TINTRA C15 WAS FIXATED USING VICRYL SUTURE (CARDINAL POINTS) AND RESORBABLE TACKS. ON (B)(6) 2017 THE PATIENT RETURNED FOR THE REPAIR OF AN INGUINAL HERNIA USING AN OPEN APPROACH DUE TO GROIN PAIN THAT WAS BEING EXPERIENCED. DURING THE COURSE OF THE OPEN INGUINAL REPAIR THE OPERATING SURGEON, SURGEON #2, FOUND THE TINTRAL C-15 FLOATING IN FLUID INSIDE THE INGUINAL HERNIA SAC. THE TINTRAC15 WAS EXTRACTED WITHOUT INCIDENT, THE HERNIA SAC CLOSED AND THE HERNIA REPAIRED USING A BASSINI TECHNIQUE. THE PATIENT REMAINS WITH THE SMALL UMBILICAL HERNIA AWAITING FUTURE REPAIR.
Patient problems: Abdominal Pain
MAUDE report 6800220 ↗
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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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