STRATAFIX SXPP1B106Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031235762), received between Feb 4, 2025 and Jun 4, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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.

• MalfunctionJun 4, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING A CERVICAL LAMINOPLASTY, THERE WAS NO PROBLEM WHEN THE PACKAGE WAS OPENED, BUT THE SUTURE WAS BROKEN SUDDENLY AT THE PROXIMAL END PART ABOUT A QUARTER OF IT WHEN THE NEEDLE WAS USED TO THE PATIENT AND THE SUTURE WAS PULLED. NO CONTACT WITH SHARP INSTRUMENTS DURING USE OR HAND OVER IT. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22144765 ↗
• InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY FOR SPINAL DISEASE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USE. POST-OP, SURGICAL SITE INFECTION OCCURRED A FEW DAYS AFTER THE PROCEDURE. IT WAS STATED THE SAME DOCTOR CONTINUED TO USE THE BARBED SUTURE ON THE SUBCUTANEOUS DERMIS FOR SPINAL DISEASE CASES IN GENERAL BEFORE 2020. ACCORDING TO THE DOCTOR, THERE HAVE BEEN SEVERAL CASES OF SURGICAL SITE INFECTION RECENTLY, AND WHETHER THEY WERE CAUSED BY THE BARBED SUTURE OR NOT IS NOT CERTAIN, BUT THE DOCTOR HAS A SUSPICION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 21305216 ↗
• InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY FOR SPINAL DISEASE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USE. POST-OP, SURGICAL SITE INFECTION OCCURRED A FEW DAYS AFTER THE PROCEDURE. IT WAS STATED THE SAME DOCTOR CONTINUED TO USE THE BARBED SUTURE ON THE SUBCUTANEOUS DERMIS FOR SPINAL DISEASE CASES IN GENERAL BEFORE 2020. ACCORDING TO THE DOCTOR, THERE HAVE BEEN SEVERAL CASES OF SURGICAL SITE INFECTION RECENTLY, AND WHETHER THEY WERE CAUSED BY THE BARBED SUTURE OR NOT IS NOT CERTAIN, BUT THE DOCTOR HAS A SUSPICION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 21305214 ↗