SpineSeal Spine Sealant SS-2055Recalls & reported problems
Pramand LLC · The SpineSeal Spine Sealant is indicated as an adjuct to sutured dural repair during spine surgery to provide a watertight closure. · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00860010683729), received between Aug 27, 2026 and Aug 27, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Microbial Contamination of Device” (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. 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
- Microbial Contamination of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2026Microbial Contamination of Device
On (b)(6)2026, dose audit samples were irradiated for a routine dose audit, with sterility testing beginning (b)(6)2026 at Millstone Medical Outsourcing. By Day 7, 5 of the 10 samples exhibited growth and the final 5 samples were inadvertently discarded before the full 14-day incubation period was completed which rendered the sterility test invalid. Samples from the same lote were retested and confirmed to pass sterility testing. Root cause of the failure has not yet been fully determined and the investigation is still on-going. No events have been reported related to patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50484284 ↗
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
- DuraSeal® Exact 206520Integra Lifesciences Corporation · Sealant, dural2 reports
- Adherus NUS-106Stryker Corporation · Sealant, Dural2 reports
- Duraseal 206520Covidien LP · 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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