MAUDE Adverse Event Report: INTRINSIC THERAPEUTICS, INC BARRICAID ACD

Model Number	BAR-A8-10MM
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Implant Pain (4561); Limb Pain (4836)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If any further information is found which would change or alter any conclusions or information another follow-up will be completed.Intrinsic therapeutics will continue to monitor for updates/trends.
Event or Problem Description
Physician notified intrinsic about a patient who had what appeared to have a migration of the occlusion component (mesh) into the spinal canal.The physician who saw the patient was contacted and stated, "hi! the original implantation date was (b)(6) 2022.The patient did not have a specific injury or incident to cause this.Last xr in july 2023 showed stable implant.He had one 2-3 week span of midline axial back about two months ago.And then in the middle of march had left low back pain with left leg symptoms which felt similar to his preop symptoms but these improved after a few days.The plan right now is to update mri lumbar spine and then go from there since his symptoms have improved".

• Brand Name: BARRICAID ACD
• Common Device Name: BARRICAID
• Manufacturer (Section D): INTRINSIC THERAPEUTICS, INC; 30 commerce way; woburn MA 01801
• Manufacturer (Section G): INTRINSIC THERAPEUTICS, INC; 30 commerce way; woburn MA 01801
• Manufacturer Contact: rachael nelsen ; 30 commerce way; woburn, MA 01801
• MDR Report Key: 19229510
• Report Number: 3006232063-2024-00016
• Device Sequence Number: 17865465
• Product Code: QES
• UDI-Device Identifier: M906BARA810MM0
• UDI-Public: M906BARA810MM0
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P160050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 05/02/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2023
• Device Model Number: BAR-A8-10MM
• Device Catalogue Number: 2731015-A8
• Device Lot Number: 11172003
• 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: 04/03/2024
• Initial Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2020
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male