MAUDE Adverse Event Report: PRAMAND, LLC CRANISEAL DURAL SEALANT

Model Number	CS-2055
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	03/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient had craniseal dural sealant placed following a chiari decompression on (b)(6) 2025.Following the chiari decompression, an alloderm patch was sutured into the dura using 5-0 prolene sutures.Prior to craniseal application, two valsalva maneuvers were performed and a small amount of csf egress was noted.The entire sealant volume of the craniseal was injected over the dural incision line.After application it was noted that there was no csf egress.Craniseal application was performed per the clinical protocol and ifu with no noted device malfunctions, complications, or adverse events reported post operatively.Patient was discharged on (b)(6) 2025 without complication.It was reported that on (b)(6) 2025 patient reported complaints of worsening back pain and paraesthesias in all four extremities.The wound of the patient had healed and she denied headache, occipital pain, neck pain, difficulty swallowing, fever, chills, or other acute complaints.Patient received head, cervical, and thoracic mri without contrast.Imaging confirmed extradural csf leak posterior to the craniectomy/laminectomy site.Patient was discharged with a follow up scheduled 4-6 weeks from the event.Review of the device history records for the lots shipped to the site indicate that the devices were manufactured to specification.All sterilization requirements were met.A root cause for the csf leak could not be determined from the available information.
Event or Problem Description
It was reported that a patient presented to the emergency department with worsening back pain and paraesthesias in all four extremities several weeks after receiving the craniseal dural sealant device in a craniotomy.Mri imaging confirmed fluid collection posterior to the craniectomy/laminectomy site.

• Brand Name: CRANISEAL DURAL SEALANT
• Common Device Name: DURAL SEALANT
• Manufacturer (Section D): PRAMAND, LLC; 201 burlington road; north building, second floor; bedford MA 01730
• Manufacturer (Section G): PRAMAND, LLC; 201 burlington road; north building, second floor; bedford MA 01730
• Manufacturer Contact: julia doroshenko ; 201 burlington road; north building, second floor; bedford, MA 01730 ; 7815401626
• MDR Report Key: 22009385
• Report Number: 3016980830-2025-00001
• Device Sequence Number: 17450336
• Product Code: NQR
• UDI-Device Identifier: 00860010683705
• UDI-Public: (01)00860010683705(10)
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P220014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CS-2055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALLODERM PATCH.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Weight: 136 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White