Stratafix Spiral SXMD2B407Recalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · 2FS-2 3-0 UNDYD MONODERM 14X14 · Class 2 · Implant
All models of Stratafix Spiral (24)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031208087), received between Nov 6, 2020 and Oct 29, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Material Separation1
- Separation Problem1
Patient problems
- Foreign Body In Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 29, 2024Separation Problem; Separation Problem
IT WAS REPORTED ON (B)(6) 2024 THAT A NEEDLE BROKE AND FELL INTO THE PATIENT INTRAOPERATIVELY. INTERVENTION WAS REQUIRED WHICH RESULT IN A PROCEDURAL DELAY.
Patient problems: Foreign Body In Patient
MAUDE report 20557129 ↗MalfunctionJul 20, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SAME SUTURE BROKE TWICE DURING SEWING CHIN WOUND IN SURGERY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15070112 ↗InjuryNov 6, 2020Material Separation
IT WAS REPORTED THAT DURING C-SECTION SURGERY, THE NEEDLE PULLED OFF SUTURE WHEN SEWING SKIN TISSUE. X RAYS WERE USED TO LOOK FOR THE NEEDLE BUT COULD NOT FIND IT. THE NEEDLE WAS LEFT IN THE PATIENT. CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. THE DELAY IN THE PROCEDURE WAS APPROXIMATELY 4.5 HOURS. THE PATIENT IS REPORTEDLY STABLE IN HOSPITAL NOW.
Patient problems: Foreign Body In Patient
MAUDE report 10800400 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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