Stratafix Spiral SXMD2B412Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031208124), received between Nov 10, 2023 and Dec 4, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2024Biocompatibility; Biocompatibility

  ON 29 NOV 2024, IT WAS REPORTED THAT A PATIENT RETURNED TO THE DOCTOR WITH PUS AND REDNESS OBSERVED AT THE SUTURE SITE POSTOPERATIVELY. THE PATIENT WAS PRESCRIBED ANTIBIOTICS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 20846084 ↗
• MalfunctionNov 10, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE OR PRIOR USE ON THE PATIENT,IT WAS REPORTED THAT 3 NEEDLES FROM THE PACKAGE KEPT BREAKING AND WE COULD NOT USE THEM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18111823 ↗
• MalfunctionNov 10, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE OR PRIOR USE ON THE PATIENT,IT WAS REPORTED THAT 3 NEEDLES FROM THE PACKAGE KEPT BREAKING AND WE COULD NOT USE THEM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18111820 ↗
• MalfunctionNov 10, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE OR PRIOR USE ON THE PATIENT,IT WAS REPORTED THAT 3 NEEDLES FROM THE PACKAGE KEPT BREAKING AND WE COULD NOT USE THEM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18111818 ↗