Stratafix Spiral SXMD2B408Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031208117), received between Mar 9, 2021 and Dec 9, 2021 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2021Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION: I SPOKE WITH MULTIPLE PHYSICIAN ASSISTANTS WHO WORK WITH DR. (B)(6). HE IS THE PROVIDER WHO USES THIS CODE OF SUTURE AND EXPERIENCED THE PROBLEM REPEATEDLY. THE PAS REPORTED THE ISSUES SEVERITY WITH SOME DIFFERING DEGREE OF FRUSTRATION HOWEVER THE COMMON MESSAGE WAS CONSISTENT WITH MY INITIAL REPORT. THE BARBS ON THE OPPOSITE SIDE OF THE TRANSITION POINT WOULD NOT CATCH IN THE SUBDERMAL LAYERS AND THE SUTURE WOULD SLIDE PAST ON TO THE OTHER SIDE. CLINICAL AD-HOC INFORMATION THE PA AND PHYSICIAN REPORTED, AT LEAST IN ONE CASE, THAT A PATIENT WHOM THEY WERE CLOSING ON HAD ONE OF THESE SUTURES USED. THE PATIENT THEN RETURNED TO CLINIC COMPLAINING OF BLEEDING FROM THE HEALING INCISION SITE. THEY DID NOT REPORT ANY INFECTIONS OR OTHER WORSE SYMPTOMS THAT OCCURRED; HOWEVER, THIS LEVEL OF PRODUCT FAILURE WAS UNACCEPTABLE. THERE WERE TWO LOT NUMBERS ON THE SAME CODE OF SUTURE WHICH THE CUSTOMER EXPERIENCED ISSUES WITH: B802ADT AND B929MMM. IT WAS UNREASONABLE TO DETERMINE EXACTLY WHICH BOXES WERE ONES CONTAINING FAILED SUTURE AND THOSE BOXES REMAINING ON THE SELF WITH THOSE SAME LOT NUMBERS COULD HAVE MORE. IMPACTED PRODUCT ADDITIONAL INFORMATION - THERE WERE TWO LO

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12968470 ↗
• InjuryMar 9, 2021Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE END USER THE SUTURE CAUSED AN INTERNAL BLEEDING AND THEREFORE THE WOUND DIDN'T PROPERLY HEAL. THE SURGEON HAD TO REMOVE THE SUTURE. INITIAL PROCEDURE: PLACEMENT OF A PLATE. THERE IS NO ADDITIONAL INFORMATION REGARDING THE PLACEMENT OF THE PLATE OR THE SURGEON'S TECHNIQUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Impaired Healing

  MAUDE report 11449239 ↗