Stratafix Spiral SXPD2B400Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031207974), received between Jun 8, 2021 and Oct 21, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE HEALTH AUTHORITY REPORTED TO OUR DISTRIBUTOR. THE DOCTOR SUTURED THE PATIENT'S WOUND WITH SUTURE, AND THE PATIENT WAS DISCHARGED AFTER RECOVERING WELL AFTER SURGERY. ON THE 47TH DAY AFTER SURGERY, THE PATIENT COMPLAINED OF REDNESS AND SWELLING IN THE WOUND, AS WELL AS DISCHARGE OF SECRETIONS. DURING THE DOCTOR'S EXAMINATION OF THE WOUND, IT WAS FOUND THAT THE SUTURE WAS NOT ABSORBED. THE DOCTOR IMMEDIATELY CHANGED THE DRESSING AND REMOVED THE SUTURE, AND PROVIDED RELEVANT HEALTH EDUCATION TO THE PATIENT BEFORE INSTRUCTING THEM TO CONTINUE OBSERVING THE CONDITION.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 17981995 ↗
• MalfunctionJun 8, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PLASTIC SURGERY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURE USED HAD NO BARBS ON IT (SMOOTH WITH NO GRAB). A NEW LIKE PRODUCT WAS OPENED AND THE CASE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11959910 ↗
• MalfunctionJun 8, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PLASTIC SURGERY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURE USED HAD NO BARBS ON IT (SMOOTH WITH NO GRAB). A NEW LIKE PRODUCT WAS OPENED AND THE CASE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11959894 ↗