Stratafix Spiral SXMD1B402Recalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · RB-1 3-0 MONODERM 20CM · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031228115), received between Apr 13, 2022 and May 16, 2024 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 Component4
- Difficult to Remove1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Foreign Body In Patient2
- 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.
InjuryMay 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
OUR DISTRIBUTOR REPORTED THE DOCTOR USED SUTURE DURING SURGERY, THERE WAS A PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED AND FELL OFF INSIDE THE PATIENT'S BODY. AS PER THE REPORTER THE DOCTOR USED A C-ARM X-RAY MACHINE TO LOCATE THE NEEDLE POSITION, PERFORMED SURGERY TO REMOVE THE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19332696 ↗MalfunctionAug 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE NEEDLE BROKE WHEN SEWING IN SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THE BROKEN NEEDLE WAS RETRIEVED SHORTLY. THE PROCEDURE WAS COMPLETED, AND NO PATIENT CONSEQUENCE REPORTED. THERE IS NO REPORT ON PATIENT INJURY.
Patient problems: Foreign Body In Patient
MAUDE report 17564909 ↗MalfunctionJun 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
PER USER FACILITY, MEDWATCH FORM, #MW5118136, DURING "A POST OPERATIVE X-DAYWAS TAKEN IN PACU AND A SMALL FOREIGN OBJECT WAS NOTED ON THE X-RAY OF THE RIGHTKNEE. IT WAS DETERMINED WITH THE SHAPE AND SIZE THAT IT IS MOST LIKELY THE TOP OF THE STRATAFIX SUTURE NEEDLE USED TO CLOSE THE CAPSULE OF THE KNEE. SURGEON ISAWARE AND VIEWED X-RAY OF THE RIGHT KNEE. SURGEON STATED IT WOULD BE MOREHARMFUL TO THE PATIENT TO ATTEMPT TO RETRIEVE.
Patient problems: Foreign Body In Patient
MAUDE report 17192935 ↗MalfunctionApr 27, 2023Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component
IT WAS REPORTED BY THE HEALTH AUTHORITY TO OUR DISTRIBUTOR, AT 10:30 AM IT WAS REPORTED, THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WHEN THE SURGEON ATTEMPTED TO SEW ANTERIOR CERVICAL FASCIA. RESULTING IN NEEDLE LOSS AND RE SUTURING, DELAYING THE SURGICAL TIME. AFTER FINDING THE BROKEN NEEDLE, CHANGED ANOTHER ONE TO COMPLETE THE SURGERY.
Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions
MAUDE report 16825567 ↗MalfunctionApr 13, 2022Difficult to Remove
IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED IN THE SURGERY . CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT''S INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14102772 ↗
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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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