Stratafix Spiral SXPD2B412Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031208001), received between Jun 17, 2022 and Aug 15, 2024 — 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.

• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS PER THE REPORTER THE PATIENT WAS DIAGNOSED WITH A SPREAD OF SUTURES DURING THE CHECK-UP. THE PATIENT NEEDED TO RE-SEW. EVEN THOUGH REQUESTED IT IS UNKNOWN WHEN INDEX SURGICAL PROCEDURE OCCURRED. AT THIS TIME NO ROOT CAUSE CAN BE IDENTIFIED.

  Patient problems: Genital Bleeding

  MAUDE report 19989949 ↗
• InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT POST- OP ORTHOPEDIC PROCEDURES, 2 SEPERATE DOCTORS HAVE HAD AN INCREASE IN SUTURE LINE REACTIONS. THESE REACTIONS ARE LOCALIZED TO THE SUBCUTANEOUS LAYER, WHICH ARE BEING CLOSED WITH STRATAFIX BIDIRECTIONAL PDO. THE REACTION CONSISTS OF LITTLE RED DOTS THAT BEGIN AT THE BOTTOM OF THE INCISION LINE AND ARE PUSS FILLED. ONCE ONE HEALS, IT APPEARS THAT ANOTHER FORMS ABOUT A 1 CM ABOVE IT. THE 1 PATIENT HAD SUCH A BAD REACTION THE PDO SUTURE HAD TO BE REMOVED AND NYLON PUT IN INSTEAD. NOTHING HAS CHANGED WITH TECHNIQUE, CLOSING PROCEDURES, OR PAS.

  Patient problems: Purulent Discharge; Reaction to Medicinal Component of Device

  MAUDE report 14737925 ↗