Stratafix Spiral SXPL2B401Recalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · 2CT-3 -1- CL PPN 14X14 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
- 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 10705031208193), received between Apr 3, 2025 and Apr 3, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Material Fragmentation” (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
- Material Fragmentation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 3, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED ON (B)(6) 2025 THAT A NEEDLE BROKE INTRAOPERATIVELY. THE NEEDLE FRAGMENTS WERE ALL SUCCESSFULLY REMOVED FROM THE SITE AND NO PATIENT INJURY WAS REPORTED; HOWEVER, INTERVENTION WAS REQUIRED.
Patient problems: Foreign Body In Patient
MAUDE report 21763884 ↗
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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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