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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTRINSIC THERAPEUTICS, INC BARRICAID ACD
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INTRINSIC THERAPEUTICS, INC BARRICAID ACD Back to Search Results
Model Number BAR-A8-8MM
Device Problem Material Twisted/Bent (2981)
Patient Problem Vertebral Fracture (4520)
Event Date 11/08/2023
Event Type  malfunction  
Event Description
During implantation the mesh (occlusion barrier) did not enter the defect and was pushed towards the opposite vertebral body.This caused the implant to be damaged on insertion.The removal tool was used to remove the partially implanted device.
 
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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 Key18242733
MDR Text Key330246387
Report Number3006232063-2023-00044
Device Sequence Number1
Product Code QES
UDI-Device IdentifierM906BARA88MM0
UDI-PublicM906BARA88MM0
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 11/30/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberBAR-A8-8MM
Device Catalogue Number2730815-A8
Device Lot Number06152303
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/08/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/27/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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