MAUDE Adverse Event Report: INTRINSIC THERAPEUTICS, INC BARRICAID ACD

Model Number BAR-A8-8MM

Device Problem Fracture (1260)

Patient Problem Vertebral Fracture (4520)

Event Date 12/13/2022

Event Type  malfunction  

Event Description

Surgeon's initial attempt to implant a barricaid device was into s1, after striking the strike cap began to bounce then the guidewire broke.Device was removed using removal tool and a second implant attempt was successful on the opposing vertebral body (l5).

• 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: 16138890
• MDR Text Key: 308469889
• Report Number: 3006232063-2022-00052
• 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: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: Yes
• 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: 04182201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2022
• 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): Other
• Patient Age: 42 YR