Stratafix Spiral SXPD2B402Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031207882), received between May 27, 2022 and Jul 2, 2024 — classified as 1 injury, 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2024Difficult or Delayed Positioning; Difficult or Delayed Positioning

  THE DOCTOR USED SUTURE TO REPAIR AND SUTURE THE UTERUS DURING THE SURGERY. DURING THE KNOTTING PROCESS, THE SUTURE BROKE, CAUSING WASTAGE OF CONSUMABLES AND DELAYING THE SURGERY TIME. THERE WAS ALSO A RISK OF THE NEEDLE FALLING INTO THE PATIENT'S PELVIC CAVITY. NO ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 19659338 ↗
• MalfunctionSep 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE HEALTH AUTHORITY REPORTED TO OUR DISTRIBUTOR, AFTER REMOVING THE UTERINE LESION DURING THE SURGERY, THE DOCTOR NEEDED TO USE SUTURE TO SUTURE THE UTERUS. DURING THE SUTURING PROCESS, THE NEEDLE BROKE DURING THE PROCESS OF REMOVING THE NEEDLE FROM THE UTERINE WOUND, CAUSING THE PROBLEM OF PULLING OFF SUTURE NEEDLE. THE DOCTOR PROMPTLY DISCOVERED AND REMOVED THE NEEDLE, AND CONTINUED TO COMPLETE THE OPERATION AFTER REPLACING IT. THIS EVENT INCREASED THE SURGICAL TIME AND INCREASED THE RISK OF INFECTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 17836454 ↗
• MalfunctionJun 23, 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 CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT''S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE BROKEN NEEDLE WAS RETRIEVED SHORTLY. THE PROCEDURE WAS COMPLETED AND NO PATIENT CONSEQUENCES.

  Patient problems: Foreign Body In Patient

  MAUDE report 17192900 ↗
• MalfunctionMay 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE HEALTH AUTHORITY REPORTED TO OUR DISTRIBUTOR, AFTER THE NEEDLE PASSED THROUGH THE FIBROID, IT WAS SLIGHTLY PULLED AND THERE WAS A PROBLEM WITH THE NEEDLE PULLING FREE FROM THE SUTURE. THE NEEDLE REMAINED IN THE PATIENT'S BODY, AND THE SURGERY WAS IMMEDIATELY SUSPENDED. THE DOCTOR SEARCHED FOR A LONG TIME IN THE ABDOMINAL CAVITY BEFORE FINDING AND REMOVING THE NEEDLE. CHANGED TO ANOTHER DEVICE TO COMPLETE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16869187 ↗
• MalfunctionSep 28, 2022Material Separation

  OUR DISTRIBUTOR IS REPORTING THE DURING THE SUTURING PROCESS, THE SUTURE''S NEEDLE AND LINE SEPARATED. THE SURGERY WAS DELAYED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15499534 ↗
• MalfunctionMay 27, 2022Break

  BREAKAGE NEEDLE. IT WAS INITIALLY REPORTED (B)(6) 2022 THAT THE NEEDLE BROKE WHEN SEWING DURING MYOMECTOMY PROCEDURE AT THE SECOND STITCH . CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT OF PATIENT INJURY. ADDITIONAL INFORMATION WAS LATER RECEIVED (B)(6) 2022 INDICATING INTERVENTION. IT WAS REPORTED THAT THE NEEDLE HAD FALLEN INTO THE BODY AND WAS RETRIEVED WITH A NEEDLE HOLDER; NO INJURY OR FURTHER INCIDENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14525256 ↗