Barricaid® ACD (Annular Closure Device) 10mm widthRecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI M906BARA810MM0), received between Aug 8, 2022 and Sep 15, 2026 — classified as 23 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Migration” (5 reports).

1 other recall cover devices cleared under the same FDA submission (P160050); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Failure to Seal

  On (b)(6) 2026, a distributor reported to Area Vice President that this patient had experienced a reherniation. Later, a second report was made (on (b)(6) 2026) that the patient had a revision surgery for this reherniation.

  Patient problems: Hernia

  MAUDE report 50775460 ↗
• InjurySep 8, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A 10 MM IMPLANT WAS TO BE IMPLANTED IN L5 FOR A L5-S1 DISC HERNIATION. X-RAY SHOWED THE ANCHOR'S BASEPLATE ENTERED THE VERTEBRAL BODY AND PENETRATED THROUGH THE END PLATE INTO THE DISC SPACE. THE IMPLANT WAS REMOVED AND THERE WAS NO ATTEMPT TO IMPLANT THE OPPOSING VERTEBRAL BODY. ACCORDING TO THE REPORTER, THE SURGEON COULD NOT ACCESS THE IMPLANT WITH THE REMOVAL TOOL DUE TO THE IMPLANT'S ANGLE, AND THE SURGEON ULTIMATELY USED OSTEOTOMES TO REMOVE THE IMPLANT.

  Patient problems: Vertebral Fracture

  MAUDE report 22991499 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED TO THE OPERATING SURGEON WITH AN INFECTION. THE SURGEON PERFORMED A REVISIONS SURGERY TO TREAT THE INFECTION AND REMOVED THE BARRICAID DEVICE WITH THE REMOVAL TOOL.

  Patient problems: Unspecified Infection

  MAUDE report 22394872 ↗
• InjuryJun 6, 2025Migration; Failure to Seal; Migration; Failure to Seal

  THE PT "HAD A PRETTY HARD FALL" AND DEVELOPED NEW HERNIATION SYMPTOMS AT SAME LEVEL AS IMPLANT. MRI REVEALED NEW DISC HERNIATION AROUND BARRICAID, AND MOVEMENT OF MESH COMPONENT DORSALLY. THE SURGEON WENT IN AND REMOVED NEW DISC MATERIAL AND PULLED OFF THE MESH COMPONENT AS BARRICAID ANCHOR PORTION OF THE IMPLANT WAS SOLID AND NOT MOVING. PT HAS NO NEW NEURO DEFICITS OR ISSUES AND IS DOING WELL.

  Patient problems: Hernia

  MAUDE report 22157719 ↗
• InjuryNov 20, 2024Malposition of Device; Malposition of Device

  PATIENT ORIGINALLY OPERATED ON THURSDAY (B)(6). PATIENT REPORTED TO THE ER OVER THE WEEKEND COMPLAINING OF LEG PAIN ON THE OPERATED SIDE. A CT SCAN SHOWED THAT THE BARRICAID ANCHOR WAS PLACED SUCH THAT A PORTION OF THE ANCHOR WAS PROTRUDING POSTERIORLY FROM THE VERTEBRAL BODY. INTRINSIC WAS NOTIFIED OF THE ISSUE ON (B)(6) 2024. FOLLOW-UP EMAIL WITH PROCTOR DETAILED THAT THE REOPERATION WAS PERFORMED ON (B)(6). THE PROUD IMPLANT WAS REMOVED, AND A SECOND DEVICE WAS IMPLANTED ON THE OPPOSITE VERTEBRAL BODY.

  Patient problems: Limb Pain

  MAUDE report 20733875 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INTRINSIC WAS MADE AWARE OF A REOPERATION ON A BARRICAID IMPLANTED PATIENT BY THE SURGEON. THE REASON FOR REOPERATION WAS REHERNIATION WITH THE MESH MIGRATING OUT OF THE DISC SPACE. THE MESH WAS REMOVED, AND A TOTAL DISC REPLACEMENT WAS PERFORMED.

  Patient problems: Hernia

  MAUDE report 20640834 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REHERNIATED ABOUT ONE MONTH AFTER HER IMPLANT WAS PLACED ON (B)(6) 2024 BY DR. (B)(6). SHE WENT TO A DIFFERENT SURGEON (DR. (B)(6)) FOR REVISION SURGERY WHICH INCLUDED REMOVAL OF IMPLANT & AN ALIF.

  Patient problems: Hernia

  MAUDE report 20522597 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON REPORTED TO INTRINSIC THAT THE PATIENT HAD REPORTED TO THEM, "3 YEARS POST-OP WITH ACUTE LEFT LEG PAIN AND RECURRENT HNP. HAD CALLED OFFICE A YEAR AGO WITH SHORT TERM LEFT LEG PAIN THAT RESOLVED AND DIDN'T FOLLOW UP FURTHER AT THAT TIME. PERFORMED REVISION LEFT L5S1 MLD. SMALL HNP VS. SCAR TISSUE FOUND. LIGAMENT OVER BARRICAID INTACT. FELT IMMEDIATE POST OP IMPROVEMENT"

  Patient problems: Hernia

  MAUDE report 20266319 ↗
• MalfunctionSep 19, 2024Migration; Migration

  THE SURGEON REPORTED TO INTRINSIC THAT A FUSION (TLIF) WAS PERFORMED ON THIS PATIENT 3.8 YEARS (ESTIMATED) AFTER IMPLANTATION. THE PATIENT REPORTED SYMPTOMATIC BACK PAIN AT 8 MONTHS POST OPERATION AND WITHIN 3 MONTHS OF THAT REPORT THE SYMPTOMS WERE INTERMITTENT, AND THE PATIENT DECIDED TO WAIT IT OUT TO SEE IF IT IMPROVED.

  Patient problems: Implant Pain

  MAUDE report 20261644 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING DISCUSSION WITH SURGEON, HE MENTIONED THAT APPROXIMATELY 1 WEEK AFTER SURGERY, THE PATIENT WENT TO THE EMERGENCY ROOM WITH A FEVER AND HAD THE WOUND DRAINED. THE PATIENT IS NOW FINE.

  Patient problems: Unspecified Infection

  MAUDE report 20056250 ↗
• InjuryAug 7, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PHYSICIAN FIRST CONTACTED INTRINSIC REPRESENTATIVE ON JULY 09TH TO STATE THERE WAS AN INFLAMMATORY RESPONSE TO THE IMPLANT. ON (B)(6) 2024 THE SITE WAS ASPIRATED AND CULTURED AND NO CSF LEAK OR BACTERIAL CULTURES WERE OBSERVED. A FOLLOW-UP SURGERY WAS PERFORMED ON (B)(6) 2024 WHERE THE BARRICAID IMPLANT WAS REMOVED AND THERE WAS A CONFIRMED SEROMA.

  Patient problems: Limb Pain; Seroma

  MAUDE report 19932752 ↗
• InjuryJun 7, 2024Difficult to Advance; Failure to Seal; Difficult to Advance; Failure to Seal

  INITIAL SURGERY WAS A LEFT SIDED L45 MLD, TO ADDRESS A 4X9MM DEFECT IN THE DISC WALL. A 10MM BARRICAID WAS IMPLANTED AND WAS NOT PROPERLY DEPLOYED ON INITIAL FLUORO (THE BARRIER APPEARS TO BE SUB-ANNULAR). THE DEVICE WAS NOTED AS BEING UNABLE TO ADVANCE FURTHER. 6-WEEK POST-OP PATIENT REPORTED SOME MILD LEFT LATERAL CALF TINGLING THAT STARTED A FEW DAYS PRIOR TO VISIT. IMAGING SHOWS MOVEMENT OF MESH (OCCLUSION COMPONENT) AND TITANIUM ANCHOR. A REVISIONS SURGERY TO DECOMPRESS THE SPACE AND PERFORM A FUSION WAS PERFORMED AND THE SYMPTOMS WERE REPORTED TO BE RESOLVED IMMEDIATELY.

  Patient problems: Numbness

  MAUDE report 19489751 ↗
• InjuryMay 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DEVICE AND DISC MATERIAL SUBSIDED SUPERIORLY INTO A VOID IN THE OPPOSING VERTEBRA, PHYSICIAN NOTES STATED THERE WAS OSTEOLYSIS. THE DISC HEIGHT COLLAPSED AND REQUIRED FUSION TO ADDRESS THE PATIENT'S BACK PAIN.

  Patient problems: Osteolysis

  MAUDE report 19281536 ↗
• MalfunctionMay 2, 2024Migration; Migration

  PHYSICIAN NOTIFIED INTRINSIC ABOUT A PATIENT WHO HAD WHAT APPEARED TO HAVE A MIGRATION OF THE OCCLUSION COMPONENT (MESH) INTO THE SPINAL CANAL. THE PHYSICIAN WHO SAW THE PATIENT WAS CONTACTED AND STATED, "HI! THE ORIGINAL IMPLANTATION DATE WAS (B)(6) 2022. THE PATIENT DID NOT HAVE A SPECIFIC INJURY OR INCIDENT TO CAUSE THIS. LAST XR IN JULY 2023 SHOWED STABLE IMPLANT. HE HAD ONE 2-3 WEEK SPAN OF MIDLINE AXIAL BACK ABOUT TWO MONTHS AGO. AND THEN IN THE MIDDLE OF MARCH HAD LEFT LOW BACK PAIN WITH LEFT LEG SYMPTOMS WHICH FELT SIMILAR TO HIS PREOP SYMPTOMS BUT THESE IMPROVED AFTER A FEW DAYS. THE PLAN RIGHT NOW IS TO UPDATE MRI LUMBAR SPINE AND THEN GO FROM THERE SINCE HIS SYMPTOMS HAVE IMPROVED"

  Patient problems: Implant Pain; Limb Pain

  MAUDE report 19229510 ↗
• InjuryMar 12, 2024Failure to Seal; Failure to Seal

  INTRINSIC BECAME AWARE ON 30-JAN-2024 THAT A PATIENT IMPLANTED WITH A 10MM BARRICAID IMPLANT ON (B)(6) 2020 HAD SUFFERED A POSSIBLE REHERNIATION AND WAS BEING TREATED CONSERVATIVELY. INTRINSIC LATER BECAME AWARE ON 19-FEB-2024 OF A REOPERATION WHERE SURGICAL INTERVENTION WAS PERFORMED (TLIF). THE REOPERATION NOTES AND IMAGES FOR THIS CASE SHOWED THE MESH HAD MIGRATED POSTERIORLY AND THERE WERE END PLATE CHANGES OBSERVED IN L5 VERTEBRAL BODY.

  Patient problems: Hernia

  MAUDE report 18886536 ↗
• InjuryOct 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER IMPLANTATION OF THE DEVICE, A REPORT FROM THE PROCTOR PRESENT WAS MADE TO INTRINSIC THAT STATED, "UPON REMOVAL OF PUSHER, SURGEON IMMEDIATELY STATED THAT HE NEEDED TO REMOVE THE DEVICE DUE TO NERVE ROOT INCARCERATION". DISCUSSIONS WITH THE PROCTOR PRESENT IDENTIFIED THAT THE MESH CAUGHT/PINCHED THE NERVE ROOT ON THE INSERTION OF THE BARRICAID DEVICE AND DREW THE NERVE ROOT INTO THE DISC SPACE ALONG WITH THE MESH OF THE IMPLANT. NO ISSUES WITH NERVE ROOT RETRACTION WERE NOTED DURING THE PREPARATION FOR IMPLANTATION. NEUROMONITORING WAS NORMAL THROUGHOUT SURGERY. THE REMOVAL TOOL WAS USED TO REMOVE THE IMPLANT AND FREE THE AFFECTED NERVE ROOT.

  Patient problems: Numbness

  MAUDE report 17889642 ↗
• InjurySep 19, 2023Migration; Migration

  THE SURGEON REPORTED ON (B)(6) 2023: APPARENT ANCHOR MIGRATION AND OCCLUSION COMPONENT MIGRATION. FROM THE SURGEON: "YEAH SHE HURTS. SMALL RECURRENT DISC MATERIAL I THINK ON MRI. SHE IS NOT A GOOD CANDIDATE FOR LATERAL...SUPER HIGH CREST, AND ALIF WOULD BE TOUGH DUE TO VASCULAR ANATOMY. SO MY PLAN IS TO TAKE OUT BARRICAID AND TLIF." THE DEVICE WAS EXPLANTED ON (B)(6) 2023 AND SENT FOR ANALYSIS TO 3RD PARTY LABORATORY.

  Patient problems: Hernia; Pain

  MAUDE report 17777048 ↗
• MalfunctionAug 14, 2023Fracture; Fracture

  PER SURGICLOUD NOTES: "NITINOL WIRE SNAPPED AT BASE OF IMPLANT TOOL. DR. (B)(6) BELIEVE(SIC) THE SNAPPED WIRE HIT DURA AND CAUSED DURAL TEAR WHICH HAD TO BE REPAIRED WITH DURA SEAL AND SUTURE DUE TO TEAR" THE REMOVAL TOOL WAS USED TO REMOVE THE PARTIALLY IMPLANTED ANCHOR FROM THE VERTEBRA.

  Patient problems: Nerve Damage

  MAUDE report 17541964 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WHILE REVIEWING CP-013 STUDY SUBJECTS, IT WAS DISCOVERED THAT APPROXIMATELY 2 MONTHS POST-OP, A PATIENT EXPERIENCED A REHERNIATION AROUND THE BARRICAID MESH AND REQUIRED A REOPERATION. ADVERSE EVENT STATUS IS RESOLVED (WITHOUT SEQUELAE). THE DEVICE WAS LEFT IMPLANTED AND DID NOT SHOW ANY EVIDENCE OF DEVICE MALFUNCTION.

  Patient problems: Hernia

  MAUDE report 17174855 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS INITIALLY IMPLANTED WITH BARRICAID DEVICE ON (B)(6) 2022. A REOPERATION OCCURRED ON (B)(6) 2023 TO PERFORM AN ALIF DUE TO PATIENT EXPERIENCING INSTABILITY. DURING THE ALIF SURGERY, THE SURGEON REMOVED THE BARRICAID DEVICE.

  Patient problems: Joint Laxity

  MAUDE report 16324268 ↗
• InjuryDec 19, 2022Migration; Migration

  PATIENT HAD BARRICAID IMPLANTED ON (B)(6) 2022 AND WAS RECOVERING NORMALLY. SURGEON REPORTED SOME NUMBING AND PAIN DOWN THE PATIENTS LEG ON (B)(6) 2022. XRAY WAS ORDERED. CT WAS ORDERED AND SHARED WITH INTRINSIC ON (B)(6) 2022 WHICH CONFIRMED POTENTIAL MIGRATION OF THE OCCLUSION COMPONENT BARRIER WITH POSSIBLE REHERNIATION. MRI HAS BEEN ORDERED AS WELL BUT INTRINSIC HAS NOT RECIEVED THESE IMAGES AS OF (B)(6) 2022.

  Patient problems: Hernia; Limb Pain; Numbness

  MAUDE report 16003602 ↗
• InjuryNov 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH POSSIBLE REHERNIATION, AND REVISION SURGERY WAS PERFORMED. DURING REVISION SURGERY, THE BARRICAID DEVICE WAS FOUND TO BE IN PROPER POSITION AND PERFORMING APPROPRIATELY. DEVICE WAS NOT TOUCHED, NO REHERNIATION WAS FOUND, NO NEW DEFECT IN THE DISC WAS PRESENT. SCAR TISSUE/ADHESIONS WERE FOUND COMPRESSING THE NERVE.

  Patient problems: Scar Tissue

  MAUDE report 15878326 ↗
• MalfunctionNov 28, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A BARRICAID IMPLANTATION WAS ATTEMPTED THROUGH A 4MM TALL BY 8MM WIDE DEFECT IN L5/S1. THE SURGEON CHOSE TO IMPLANT INTO THE S1 VERTEBRAL BODY AND NOTED THAT THE BONE WAS HARDER THAN WHAT HE TYPICALLY HAS ENCOUNTERED. DURING IMPLANTATION, THE NITINOL MESH GUIDE FRACTURED, AND THE IMPLANT WAS REMOVED. A SECOND IMPLANT ATTEMPT WAS MADE AND WAS SUCCESSFUL.

  Patient problems: Vertebral Fracture

  MAUDE report 15871757 ↗
• MalfunctionNov 23, 2022Fracture; Fracture

  INITIAL IMPLANTATION ATTEMPT MISSED THE DEFECT IN THE DISC SURFACE. AFTER A FEW IMPACTS WITH THE MALLET, THE NITINOL GUIDE WIRE THAT HOLDS THE IMPLANT BROKE. THE IMPLANT AND WIRE WERE REMOVED WITHOUT ANY PATIENT HARM. A SECOND IMPLANTATION ATTEMPT WAS SUCCESSFUL WITH A NEW DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15854350 ↗
• MalfunctionNov 21, 2022Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress

  SURGEON INSERTING THE BARRICAID IMPLANT AND NOTICED THE MESH STARTING TO BUCKLE. THE SURGEON THEN REMOVED THE FAILED IMPLANT WITH MESH BUCKLING AND ATTEMPTED A SECOND IMPLANTATION USING THE SAME DAMAGED IMPLANT. THE BUCKLED MESH THEN CONTINEUD TO BUCKLE AND IT DETACHED FROM THE ANCHOR. THEN THE SURGEON REMOVED THE NOW SEPARATED MESH AND SUNK THE IMPLANT FURTHER INTO THE VERTEBRAL BODY. ANCHOR REMAINS IMPLANTED AND THE PATIENT WAS CLOSED UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15833355 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P160050. One submission often covers many models, so check the product and lot details in each record.

• Z-2798-2020 · Jul 24, 2020 · Terminated
  Barricaid Annual Closure Device (ACD) BAR-A8-8MM - Product Usage: The Barricaid ACD is indicated for reducing the incidence of reherniation, and reoperation in skeletally mature pa