MAUDE Adverse Event Report: INTRINSIC THERAPEUTICS, INC BARRICAID ACD

Model Number BAR-A8-8MM

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/02/2024

Event Type  Injury  

Event Description

The surgeon was concerned about proximity to the nerve root and did not align the occlusion component with the defect.Significant occlusion component buckling encountered during implantation.Implant was removed prior to being fully implanted and countersunk.Removal was done successfully with no issues.Image in sc shows a fractured nitinol guide from one end.Removal tool was utilized.

• 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
• MDR Report Key: 18497813
• MDR Text Key: 332700382
• Report Number: 3006232063-2024-00002
• Device Sequence Number: 1
• Product Code: QES
• UDI-Device Identifier: M906BARA88MM0
• UDI-Public: M906BARA88MM0
• 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: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BAR-A8-8MM
• Device Catalogue Number: 2730815-A8
• Device Lot Number: 06152302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2023
• 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