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 07/26/2021

Event Type  Injury  

Manufacturer Narrative

Poor retraction affecting delivery tool positioning during the first implantation session.

Event Description

Removed a barricaid implant that has ended in suboptimal final position in s1, due to a problem with poor tubular retractor position (physician's technique issue).After implantation, the decision was made to remove the implant.Removal was uneventful.A new barricaid implant was implanted again with the opposing endplate l5.Second implantation was successful.

• 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: regina shih ; 30 commerce way; woburn, MA 01801 ; 5083696545
• MDR Report Key: 12395907
• MDR Text Key: 269775484
• Report Number: 3006232063-2021-00018
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2023
• Device Model Number: BAR-A8-10MM
• Device Catalogue Number: BAR-A8-10MM
• Device Lot Number: 11172003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2019
• 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