DuraSeal Exact Spinal Sealant System 206520Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10381780000044), received between Jan 23, 2025 and Feb 20, 2026 — classified as 9 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Improper Chemical Reaction” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Improper Chemical Reaction

  AN AUTHORIZED DISTRIBUTOR REPORTED THAT DURING SPINE TUMOR SURGERY, DURASEAL EXACT SPINE SEALANT SYSTEM 5ML (206520) COULD NOT TURN INTO HYDROGEL FORMATION WHILE IN CONTACT WITH THE PATIENT. THERE WAS NO PATIENT INJURY OR SURGICAL DELAY. USER FACILITY: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24405685 ↗
• MalfunctionDec 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23733473 ↗
• InjuryOct 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Post Operative Wound Infection

  MAUDE report 23212548 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22549468 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22549464 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22549394 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22549393 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22549392 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22549268 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22549267 ↗
• MalfunctionJul 10, 2025Improper Chemical Reaction; Improper Chemical Reaction

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22470627 ↗
• InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS RELATED TO THE FOLLOWING 4 REPORTS: 3003418325-2025-00026 3003418325-2025-00025. 3003418325-2025-00027. 3003418325-2025-00028. A FACILITY REPORTED THAT IN A RETROSPECTIVE ANALYSIS SINCE THE BEGINNING OF 2025, SURGICAL INFECTIONS WERE FOUND IN CORRELATION TO DURASEAL EXACT SPINE SEALANT SYSTEM 5ML US BOX OF 5 (206520). PER CUSTOMER, A TOTAL OF 5 INFECTIONS WERE FOUND (4 TO MICROMYST AND 1 TO DURASEAL).

  Patient problems: Post Operative Wound Infection

  MAUDE report 22302439 ↗
• MalfunctionMar 7, 2025Improper Chemical Reaction; Improper Chemical Reaction

  A FACILITY REPORTED THAT WHILE IN CONTACT WITH A PATIENT, DURASEAL EXACT SPINE SEALANT SYSTEM (206520) COULD NOT TURN INTO HYDROGEL FORMATION. THERE WAS NO PATIENT INJURY AND NO DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21547867 ↗
• MalfunctionFeb 13, 2025Improper Chemical Reaction; Improper Chemical Reaction

  A FACILITY REPORTED THAT WHILE IN CONTACT WITH A PATIENT, DURASEAL EXACT SPINE SEALANT SYSTEM (206520) COULD NOT TURN INTO HYDROGEL FORMATION. THERE WAS NO PATIENT INJURY AND NO DELAY IN SURGERY NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21380292 ↗
• MalfunctionJan 23, 2025Improper Chemical Reaction; Improper Chemical Reaction

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21219231 ↗