Stratafix Spiral SXMD2B402Recalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · 2RB-1 2-0 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031208094), received between May 27, 2021 and Apr 26, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).
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
- Detachment of Device or Device Component3
- Device Fell1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Needle Stick/Puncture1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AS PER THE REPORTER, THE DOCTOR OPENED THE PACKAGING AND FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED BEFORE STITCHING. THE NEEDLE FELL INTO THE PATIENT''S ABDOMINAL CAVITY, AND THE ENDOSCOPE ASSISTED IN FINDING AND REMOVING IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19198592 ↗MalfunctionOct 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
OUR DISTRIBUTOR REPORTED THE NEEDLE DETACHED FROM THE SUTURE. ON 9/25/2023 ADDITIONAL INFORMATION WAS RECEIVED INDICATING, THE NEEDLE FELL INTO THE PATIENT, BUT IT WAS RETRIEVED. THE NEEDLE WAS RETRIEVED IN THE SAME PROCEDURE, LAPAROSCOPIC PROCEDURE. THE BROKEN PIECE INSIDE THE PATIENT WAS LOCATED WITH THE LAPAROSCOPIC CAMERA. THE PATIENT IS REPORTEDLY IN GOOD CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17861521 ↗MalfunctionSep 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
OUR DISTRIBUTOR REPORTED: THE CLINICIAN STATED THAT THE THREAD DOES NOT HAVE THE SAME TIGHTNESS AS ALWAYS. THE SUTURE RELEASES. THE NEEDLE DETACHED FROM THE THREAD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ON 09/25/2023 INFORMATION WAS RECEIVED WHICH INDICATED THE NEEDLE FELL INTO THE PATIENT, BUT IT WAS RETRIEVED. IN THE SAME LAPAROSCOPIC PROCEDURE. THE BROKEN PIECE INSIDE THE PATIENT WAS LOCATED WITH THE LAPAROSCOPIC CAMERA. THE PATIENT IS REPORTED TO BE IN GOOD CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17842257 ↗MalfunctionJul 19, 2023Material Separation; Material Separation
THE DISTRIBUTOR REPORT LISTED THE FOLLOWING, LOOSE NEEDLE TIP AT SUTURE POINT. IT ALSO STATED THE FAILURE AS BREAKAGE NEEDLE. A CLEAR EXPLANATION OF THE FAILURE OR EVENT WAS NOT DISCLOSED. NO OTHER DETAILS COULD BE OBTAINED.
Patient problems: Needle Stick/Puncture
MAUDE report 17356850 ↗MalfunctionMay 27, 2021Device Fell
NEEDLE FELL OFF THE SUTURE WHILE SUTURING THE ANASTOMOSIS AFTER PROSTATECTOMY. THE NEEDLE FELL INTO THE SURGICAL SITE. IT WAS FOUND AFTER 10 MINUTES. NO PATIENT CONSEQUENCES REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11893800 ↗
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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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