Stratafix Spiral SXMD2B403Recalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · 2RB-1 3-0 U MND 16X16 13MM LDR · Class 2 · Implant
All models of Stratafix Spiral (24)
Data updated Oct 16, 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 10705031208100), received between Oct 18, 2022 and Oct 18, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Loose or Intermittent Connection1
Patient problems
- Failure to Anastomose2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 18, 2022Loose or Intermittent Connection
THE END USER REPORTED TO OUR DISTRIBUTOR THERE WAS ANASTOMOSIS OF URETHRA. THE DEVICE CAME LOOSE POSTOPERATIVELY (ANASTOMOSIS INSUFFICIENCY). ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT WAS COMPLIANT WITH POST-OP INSTRUCTIONS. THE PATIENT IS REPORTED TO BE DOING FINE.
Patient problems: Failure to Anastomose
MAUDE report 15629714 ↗InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem
THE SURGEON REPORTED TO OUR DISTRIBUTOR THAT THERE HAS BEEN AN INCREASED INCIDENCE OF ANASTOMOTIC LEAKS IN ROBOTIC PROSTATECTOMY IN THE PAST. THE PRODUCT STRATAFIX SPIRAL SXMD2B403 HAS BEEN USED FOR YEARS AND NEITHER THE HANDLING NOR THE TECHNIQUE WAS CHANGED.
Patient problems: Failure to Anastomose
MAUDE report 15629481 ↗
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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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