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Adherus NUS-106Recalls & reported problems

Stryker Corporation · Adherus AutoSpray Dural Sealant · Class 3 · Implant

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 00897146002018), received between Aug 15, 2022 and May 5, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Physical Resistance/Sticking1

Patient problems

  • Insufficient Information1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 5, 2026

    PT UNDERWENT L4-L5 LUMBAR DISCECTOMY FOR DISC HERNIATION WITH RADICULOPATHY. PER THE OPERATIVE NOTE, A DURA RENT WAS NOTED UNDERNEATH THE BONE AND COULD NOT BE REASONABLY SEWN THROUGH THE TUBE. THEREFORE, DURAL SEALANT WAS USED. THE SURGEON ASKED FOR ADHERUS DURAL SEALANT. THE OR TEAM STARTED WITH THE REGULAR, SHORT TIP SEALANT. THE SURGICAL TECH FOLLOWED THE INSTRUCTIONS ON THE PACKAGING AND WHEN THE SURGEON WENT TO USE IT, THE PRODUCT LEAKED OUT OF THE AREA OUT OF THE BOTTLES ATTACHED INSTEAD OF THE SPOUT. A SECOND DEVICE WAS OBTAINED, THIS TIME WITH THE LONGER APPLICATION TIP. AGAIN, THE INSTRUCTIONS WERE FOLLOWED STEP BY STEP WITH MULTIPLE STAFF IN THE OR FOLLOWING ALONG. THE PRODUCT AGAIN LEAKED OUT OF THE AREA WHERE THE BOTTLES ATTACHED. A THIRD DEVICE WAS OBTAINED, DIRECTIONS FOLLOWED EXACTLY AS BEFORE, AND THE THIRD TIME THE THIRD DEVICE WORKED WITH LEAKING AND WITHOUT ISSUE. TO NOTE THE STAFF IN THE OR THAT DAY WERE EXPERIENCED STAFF AND ARE MEMBERS OF THE NEURO/SPINE TEAM SO ARE FAMILIAR WITH ASSEMBLING THIS DEVICE. THERE WAS NO DEVIATION FROM THE IFU [INSTRUCTIONS FOR USE]. THIS APPEARS TO BE A PRODUCT FAILURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25080979 ↗
  • MalfunctionAug 15, 2022Physical Resistance/Sticking

    ADHERES AUTOSPRAY DURAL SEALANT MALFUNCTIONED AND BECAME STUCK WHEN TRYING TO MIX PRODUCT RESULTING IN ONLY PARTIAL MIXTURE AND INABILITY TO USE. FDA SAFETY REPORT ID# (B)(4).

    Patient problems: Insufficient Information

    MAUDE report 15233557 ↗

Other Sealant, Dural devices

All Sealant, Dural devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.