MAUDE Adverse Event Report: INTRINSIC THERAPEUTICS, INC BARRICAID ACD

Model Number BAR-A8-8MM

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Vertebral Fracture (4520)

Event Date 06/29/2022

Event Type  Injury  

Event Description

Initial target of s1 with alignment trial and device in ideal position.Fluoro confirmed mesh entering disc space with no buckling and baseplate entering in intended angle with first 2 mallet strikes.Surgeon then malleted additional 3-4 times without intermittent fluoro.Striking the cap past flush.Final lateral image showed implant had penetrated the endplate.Surgeon decided to remove implant with removal tool.

Manufacturer Narrative

Surgeon lost their hand angle during implantation and this caused the implant to deflect at an angle that was not desired.This loss of hand angle was not caught due to there being no intermittent fluro images.Eventually the surgeon hammered the implant until it penetrated the endplate of the vertebral body.Once this was observed, the device was then explanted during the inital surgery.No further implantation was attempted on the opposing 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: 15774482
• MDR Text Key: 303547082
• Report Number: 3006232063-2022-00028
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• 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: 2730815-A8
• Device Lot Number: 02122107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2021
• 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: 39 YR
• Patient Sex: Female