DuraSeal® Exact 206520Recalls & reported problems
Integra Lifesciences Corporation · DuraSeal® Exact Spine Sealant System Polymer Kit 5 mL · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780537168), received between Mar 7, 2025 and Mar 17, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Improper Chemical Reaction” (2 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.
Reports received per month
Most reported problems
Device problems
- Improper Chemical Reaction2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 17, 2025Improper Chemical Reaction; Improper Chemical Reaction
A FACILITY REPORTED THAT DURING SURGERY (SPINAL TUMOR), THE DURASEAL EXACT SPINE SEALANT SYSTEM (206520) COULD NOT TURN INTO HYDROGEL FORMATION. THE PRODUCT WAS IN CONTACT WITH A PATIENT; HOWEVER, NO PATIENT INJURY OR SURGICAL DELAY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21621723 ↗MalfunctionMar 7, 2025Improper Chemical Reaction; Improper Chemical Reaction
A FACILITY REPORTED THAT WHILE IN CONTACT WITH A PATIENT, THE DURASEAL EXACT SPINE SEALANT SYSTEM (206520) DID NOT TURN INTO HYDROGEL FORM. NO PATIENT INJURY OR SURGICAL DELAY HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21548460 ↗
Other Sealant, dural devices
- DuraSeal® 202050Integra Lifesciences Corporation · Sealant, Dural20 reports
- DuraSeal Exact Spinal Sealant System 206520Integra Lifesciences Corporation · Sealant, Dural15 reports
- DuraSeal® 202050Integra Lifesciences Corporation · Sealant, dural4 reports
- CraniSeal Dural Sealant CS-2055Pramand LLC · Sealant, Dural4 reports
- Adherus NUS-106Stryker Corporation · Sealant, Dural2 reports
- Duraseal 206520Covidien LP · Sealant, dural1 report
- SpineSeal Spine Sealant SS-2055Pramand LLC · Sealant, Dural1 report
- DuraSeal® 202010DSIntegra Lifesciences Corporation · Sealant, Dural1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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