MAUDE Adverse Event Report: STRYKER CORPORATION ADHERUS AUTOSPRAY DURAL SEALANT; SEALANT, DURAL

Model Number	NUS-106
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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.

• Brand Name: ADHERUS AUTOSPRAY DURAL SEALANT
• Common Device Name: SEALANT, DURAL
• Manufacturer (Section D): STRYKER CORPORATION; 4100 east milham ave.; kalamazoo MI 49001
• MDR Report Key: 25080979
• Report Number: 25080979
• Device Sequence Number: 13371415
• Product Code: NQR
• UDI-Device Identifier: 00897146002018
• UDI-Public: (01)00897146002018(17)270731(10)07256411
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/20/2026
• Report Date (Section F): 04/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NUS-106
• Device Catalogue Number: NUS-106
• Device Lot Number: 07256411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/05/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 69 KG
• Date Report Sent to FDA: 04/20/2026