MAUDE Adverse Event Report: INTRINSIC THERAPEUTICS, INC BARRICAID ACD

Model Number BAR-A8-10MM

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Vertebral Fracture (4520)

Event Date 03/28/2022

Event Type  malfunction  

Event Description

A barricaid implantation was attempted through a 4mm tall by 8mm wide defect in l5/s1.The surgeon chose to implant into the s1 vertebral body and noted that the bone was harder than what he typically has encountered.During implantation, the nitinol mesh guide fractured, and the implant was removed.A second implant attempt was made and was successful.

Manufacturer Narrative

Based on the surgeon narrative, imaging, and returned delivery instrument, it was confirmed that mesh guide detachment had occurred during implantation.No deviations or non-conformances were noted in the lot history review.The fluorographs provided evidence that the root cause was related to sub-optimal positioning of the delivery sheath such that the polymer barrier was being implanted directly into bone.The sub-optimal positioning may have been related to unusually high hardness of this s1 vertebral body.

• Brand Name: BARRICAID ACD
• Type of Device: 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 ; 7819320222
• MDR Report Key: 15871757
• MDR Text Key: 307701678
• Report Number: 3006232063-2022-00009
• Device Sequence Number: 1
• Product Code: QES
• UDI-Device Identifier: M906BARA810MM0
• UDI-Public: M906BARA810MM0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2023
• Device Model Number: BAR-A8-10MM
• Device Catalogue Number: 2731015-A8
• Device Lot Number: 06152002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR