MAUDE Adverse Event Report: INTRINSIC THERAPEUTICS, INC BARRICAID ACD

Model Number	BAR-A-10MM
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Hernia (2240); Numbness (2415); Limb Pain (4836)
Date of Event	04/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had barricaid implanted on (b)(6) 2022 and was recovering normally.Surgeon reported some numbing and pain down the patients leg on (b)(6) 2022.Xray was ordered.Ct was ordered and shared with intrinsic on (b)(6) 2022 which confirmed potential migration of the occlusion component barrier with possible reherniation.Mri has been ordered as well but intrinsic has not recieved these images as of (b)(6) 2022.
Additional Manufacturer Narrative
The patient appears to have experienced a barrier migration into the spinal canal according to the images shared with intrinsic.Reherniation and mesh migration are both known risks to using the barricaid device.The device remains implanted, the patient is scheduled for more imaging and is being monitored by their surgeon.
Additional Manufacturer Narrative
The patient appears to have experienced a barrier migration into the spial canal according to the images shared with intrinsic.Reherniation and mesh migration are both known risks to using the barricaid device.The device remains implanted, the patient is scheduled for more imaging and is being monitored by their surgeon.Follow-up 1: interviews with attending physician after the revision surgery revealed that the device migration was caused by a herniation at the implanted location.The removed portion of the device was sent to a 3rd party laboratory for analysis to determine if there were any structural failures of the mesh barrier (the results of this will be reported to fda within the post approval study).At this time, it is believed the device functioned according to labeled usage and this hazard occurred within the ifu expected rates.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 trends.
Event or Problem Description
Patient had barricaid implanted on (b)(6) 2022 and was recovering normally.Surgeon reported some numbing and pain down the patients leg on (b)(6) 2022.Xray was ordered.Ct was ordered and shared with intrinsic on (b)(6) 2022 which confirmed potential migration of the occlusion component barrier with possible reherniation.Mri has been ordered as well but intrinsic has not recieved these images as of (b)(6) 2022.Follow-up 1: surgeon updated intrinsic on (b)(6) 2023 that the mesh migration previously reported was removed during surgery on (b)(6) 2023 (b)(4).It was confirmed that there was a reherniation where the mesh had migrated outside the disc space.The mesh was removed but the titanium anchor was left implanted.The removed mesh was sent to a laboratory for analysis at the request of intrinsic therapeutics.

• 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 ; 7819320252
• MDR Report Key: 16003602
• Report Number: 3006232063-2022-00048
• Device Sequence Number: 20235701
• Product Code: QES
• UDI-Device Identifier: M906BARA810MM0
• UDI-Public: M906BARA810MM0
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P160050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2023

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: 05/21/2024
• Device Model Number: BAR-A-10MM
• Device Catalogue Number: 2731015-A8
• Device Lot Number: 04302119
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2022
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 36 YR
• Patient Sex: Unknown