MAUDE Adverse Event Report: INTRINSIC THERAPEUTICS BARRICAID ACD

Model Number BAR-A8-8MM

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Vertebral Fracture (4520)

Event Date 11/05/2021

Event Type  malfunction  

Event Description

Removed implant that was placed in the suboptimal position.Post operatively surgeon realized that he had lost positioning of delivery instrument.Implant removed without complications and a second device was implanted in the opposing vertebral body.

• Brand Name: BARRICAID ACD
• Type of Device: BARRICAID
• Manufacturer (Section D): INTRINSIC THERAPEUTICS; 30 commerce way; woburn MA 01801
• Manufacturer (Section G): INTRINSIC THERAPEUTICS; 30 commerce way; woburn MA 01801
• Manufacturer Contact: greg devenne ; 30 commerce way; woburn, MA 01801 ; 7819320222
• MDR Report Key: 12928942
• MDR Text Key: 283088005
• Report Number: 3006232063-2021-00021
• Device Sequence Number: 1
• Product Code: QES
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2024
• Device Model Number: BAR-A8-8MM
• Device Catalogue Number: BAR-A8-8MM
• Device Lot Number: 02122108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Prefer Not To Disclose