Barricaid® ACD (Annular Closure Device) 8mm widthRecalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI M906BARA88MM0), received between Jul 19, 2022 and Sep 21, 2026 — classified as 42 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Failure to Seal” (13 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Scar Tissue

  MAUDE report 50839786 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  Patient experienced an infection, and during a revision surgery to address the infection, the implant was removed.

  Patient problems: Unspecified Infection

  MAUDE report 50838812 ↗
• InjuryAug 6, 2026Failure to Seal

  Surgeon scheduled a re-operation for this patient due to a suspected re-herniation. Removal case was on (b)(6)2026 the device was removed prior to further surgical techniques and device was reported to be in good position.

  Patient problems: Hernia

  MAUDE report 50165114 ↗
• InjuryJul 6, 2026Failure to Seal

  PATIENT REHERNIATED AND THE MESH HAD MIGRATED POSTERIORLY. THE REVISION SURGERY WAS PERFORMED (FUSION), AND THE MESH PORTION WAS REMOVED.

  Patient problems: Hernia

  MAUDE report 25723441 ↗
• MalfunctionOct 31, 2025Migration; Failure to Seal; Migration; Failure to Seal

  BASED ON PERSONAL COMMUNICATION FROM A WORK COLLEAGUE, THE PATIENT HAD AXIAL BACK PAIN AND HAD MRI AND X-RAY IMAGING. THE IMAGES SHOWED MIGRATION OF THE MESH MARKER OUT OF THE DISC SPACE AND COMPRESSION OF THE NERVE ROOT DUE TO A REHERNIATION. THE PATIENT HAS ONLY HAD IMAGING PERFORMED AND HAS NOT YET HAD A FOLLOW-UP VISIT WITH THE SURGEON.

  Patient problems: Back pain; Dural Tear

  MAUDE report 23439498 ↗
• InjuryOct 23, 2025Failure to Seal; Failure to Seal

  ON (B)(6) 2025 THE SURGEON PERFORMED A TOTAL DISC REPLACEMENT (TDR) AND APPROACHED ANTERIORLY. THE SURGEON DETACHED THE POLYMER OCCLUSION COMPONENT AND THEN BROKE OFF THE ANCHOR HEAD AS WELL. BOTH WERE REMOVED COMPLETELY, AND NO FRAGMENTS WERE VISUALIZED VIA X-RAY. THE VERTICAL KEEL AND BASEPLATE WERE LEFT IN THE PATIENT. NO ADVERSE PATIENT OUTCOMES WERE REPORTED. FOLLOWING UP WITH THE SURGEON, IT WAS NOTED THAT THE PATIENT EXPERIENCED RECURRENT DISC PROTRUSION AND PERSISTENT DISCOGENIC PAIN AS THE NEED FOR A TDR PROCEDURE.

  Patient problems: Back pain; Limb Pain

  MAUDE report 23370898 ↗
• InjuryOct 16, 2025Failure to Seal; Failure to Seal

  THE PATIENT WAS IMPLANTED WITH A BARRICAID DEVICE ON (B)(6) 2025. THE PATIENT EXPERIENCED ANOTHER HERNIATION AT THE SAME LEVEL. THE SURGEON PERFORMED A REVISION MICRODISCECTOMY ON (B)(6) 2025 AND DID NOT REMOVE THE IMPLANT.

  Patient problems: Hernia

  MAUDE report 23314124 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A RE-OPERATION WAS SCHEDULED AS A REMOVAL AND RE-IMPLANTATION AT L5. THE SURGEON DETERMINED THAT SCAR TISSUE WAS PRESENT. THE IMPLANT WAS FOUND AS IMPLANTED, THE NERVE WAS MOBILIZED AND THE BARRICAID IMPLANT WAS LEFT IN PLACE.

  Patient problems: Insufficient Information

  MAUDE report 23020136 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED TO INTRINSIC THAT THEY HAD A STAPH INFECTION AND UNDERWENT REVISION SURGERIES TO TREAT THE INFECTION AND ULTIMATELY HAD THE BARRICAID DEVICE REMOVED.

  Patient problems: Medical device site infection

  MAUDE report 22893547 ↗
• InjuryAug 12, 2025Failure to Seal; Failure to Seal

  INTRINSIC WAS NOTIFIED THAT THE PATIENT REHERNIATED MORE THAN SIX WEEKS POST-OPERATIVELY ON (B)(6) 2025. ACCORDING TO THE SURGEON, THE HERNIATION OCCURRED NEAR THE IMPLANT, WHICH WAS REPORTED TO BE INTACT. A FUSION SURGERY WAS PERFORMED ON (B)(6) 2025, WHERE THE IMPLANT WAS PARTIALLY REMOVED TO MAKE ROOM FOR AN INTERBODY CAGE.

  Patient problems: Hernia

  MAUDE report 22782799 ↗
• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025 (APPROX. 2 MONTHS POST IMPLANTATION), IT WAS REPORTED TO AN INTRINSIC REPRESENTATIVE THAT THE PATIENT HAD A 2ND HERNIATION AT THE INDEX LEVEL. THE DOCTOR WAS PLANNING TO PERFORM A REVISION SURGERY ON (B)(6) 2025 AND AFTER THE SURGERY THEY DECIDED TO NOT REMOVE THE BARRICAID DEVICE.

  Patient problems: Hernia

  MAUDE report 22719563 ↗
• InjuryJul 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  A PHYSICIAN REPORTED TO INTRINSIC'S EMAIL ABOUT A BARRICAID REMOVAL THEY HAD PERFORMED. THE SURGEON REPORTED THE DEVICE WAS REMOVED DUE TO "IRRITATION, NERVE DAMAGE, CAUDA EQUINA, AND POSSIBLE ALLERGY (TO DEVICE MATERIALS)".

  Patient problems: Insufficient Information

  MAUDE report 22532978 ↗
• InjuryJul 16, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT WAS IMPLANTED IN L5 FOR THE L5/S1 DISC SPACE. THE PATIENT CAME BACK TO SURGEON COMPLAINING OF SIMILAR SYMPTOMS PRIOR TO IMPLANTATION SURGERY. FLUID BUILD-UP WAS FOUND AROUND THE IMPLANT, SO THE PHYSICIAN DECIDED TO REMOVE THE IMPLANT AS PART OF THE TREATMENT. THE PATIENT DID NOT PRESENT ANY SYMPTOMS OF INFECTION, AND WAS REPORTED AS DIABETIC.

  Patient problems: Limb Pain

  MAUDE report 22519150 ↗
• MalfunctionJul 11, 2025Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  THE DISC SPACE WAS VERY TIGHT. ONCE WE BEGAN TAPPING ON THE INSERTION DEVICE IT BEGAN TO BUCKLE. A REMOVAL TOOL WAS USED, AND ANOTHER ATTEMPT WAS TRIED WITH A NEW IMPLANT SINCE THE NITINOL GUIDE WIRES WERE BENT OUT OF SHAPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22479019 ↗
• MalfunctionJun 26, 2025Failure to Seal; Failure to Seal

  THE SURGEON REPORTED TO INTRINSIC THAT THE PATIENT HAD A REHERNIATION AT THE INDEX LEVEL AND PERFORMED A REOPERATION. NO DETAILS ABOUT REOPERATION PERFORMED WERE PROVIDED.

  Patient problems: Hernia

  MAUDE report 22337824 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SIXTEEN DAYS AFTER IMPLANTATION, THE PATIENT HAD A REOPERATION TO WASHING OUT THE SURGICAL SITE DUE TO AN INFECTION. TEN DAYS LATER ANOTHER WASH OUT WAS PERFORMED. TWO DAYS AFTER THE FINAL WASH OUT THE SURGEON DECIDED TO PERFORM AN ALIF WHERE THE BARRICAID DEVICE WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 22337511 ↗
• InjuryJun 13, 2025Migration; Failure to Seal; Migration; Failure to Seal

  PATIENT HAD A "HARD FALL" ON (B)(6) 2025 WITH A REHERNIATION. REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 WHERE THE MESH WAS OBSERVED TO HAVE MIGRATED OUT OF THE DISC SPACE. THE DEVICE WAS REMOVED AS PART OF THE TREATMENT FOR THE REHERNIATION.

  Patient problems: Hernia

  MAUDE report 22201958 ↗
• InjuryJun 5, 2025Failure to Seal; Failure to Seal

  THE PATIENT REPORTED TO THE SURGEON AND WAS BELIEVED TO HAVE A REHERNIATION. CONSERVATIVE THERAPY WAS PERFORMED, AND ON (B)(6) 2025 EXPLORATORY SURGERY WAS PERFORMED. THE DEVICE WAS FOUND TO NOT HAVE MOVED FROM IMPLANTED POSITION AND WAS LEFT AS IT WAS.

  Patient problems: Hernia

  MAUDE report 22149554 ↗
• InjuryMay 29, 2025Failure to Advance; Failure to Advance

  ATTEMPTED IMPLANTATION ON S1, AND THE MESH BUCKLED. IT LOOKED LIKE IT GOT CAUGHT ON THE ANNULUS. THE IMPLANTATION WAS STOPPED AND A REMOVAL TOOL WAS USED TO EXPLANT, WHICH WORKED WITHOUT INCIDENCE. UNABLE TO IMPLANT ON L5 DUE TO NERVE LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22108618 ↗
• InjuryMay 29, 2025Device Dislodged or Dislocated; Failure to Seal; Device Dislodged or Dislocated; Failure to Seal

  A PATIENT FELL AND SUFFERED A TRAUMATIC EVENT AT THE INDEX LEVEL OF A BARRICAID IMPLANT. ON (B)(6) 2025, A SURGERY WAS SCHEDULED AND PERFORMED. DURING THE REVISION SURGERY, THE SURGEON EXPOSED THE DEVICE AND REMOVED THE NEW ADDITIONAL HERNIATION AND ALSO DISCOVERED AND REMOVED PART OF A FRACTURED VERTEBRAL ENDPLATE. "THE BARRICAID DEVICE WAS FOUND TO BE STABLE AFTER PROBING. THE SURGEON STATED THE MESH PORTION OF THE DEVICE, "WAS WEDGED BETWEEN THE TWO ENDPLATES."THERAPIES FOR BONE FRACTURE(S) WERE ADMINSTERED AND THE PATIENT WAS CLOSED.

  Patient problems: Hernia; Pain; Vertebral Fracture

  MAUDE report 22108043 ↗
• MalfunctionMay 29, 2025Migration; Migration

  THE ORIGINAL IMPLANTATION ON (B)(6) 2024 WAS REPORTED AS 2 IMPLANTS USED (THE FIRST WAS REMOVED). A SECOND IMPLANT WAS INSERTED INTO THE SPACE THAT THE INITIAL DEVICE HAD CREATED. THE FINAL IMPLANTED DEVICE HAD IMAGES TAKEN AT (ESTIMATED) 5 MONTHS POST OP THAT SHOWED SOME MOVEMENT FROM THE INITIAL LOCATION. ON 30-APR-2025, A REPORT CAME IN OF A DEVICE MIGRATION OUT OF THE VERTEBRA AND A TREATMENT PLAN IS BEING DEVELOPED.

  Patient problems: Insufficient Information

  MAUDE report 22105499 ↗
• InjuryApr 3, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PHYSICIAN INFORMED THEIR SALES REPRESENTATIVE THAT THIS PATIENT HAD EXPERIENCED A PARS FRACTURE DUE TO MORE THAN NORMAL BONE REMOVAL DURING THE BARRICAID IMPLANTATION.

  Patient problems: Vertebral Fracture

  MAUDE report 21765950 ↗
• MalfunctionMar 14, 2025Failure to Seal; Failure to Seal

  PATIENT SUFFERED A REHERNIATION AT THE INDEX LEVEL. THE BARRIER WAS REMOVED FROM THE ANCHORED IMPLANT AS PART OF A REVISION SURGERY.

  Patient problems: Hernia

  MAUDE report 21608382 ↗
• MalfunctionMar 14, 2025Failure to Advance; Failure to Advance

  THE DEFECT IN THE ANULUS WAS TIGHT, AND THE IMPLANT GOT CAUGHT IN THE ANNULUS AND BUCKLED. THE IMPLANT WAS IMPACTED TO TRY AND PUSH THROUGH THE OBSTRUCTION, BUT DIDN'T SUCCEED. THE SURGEON MADE A SURGICAL INTERVENTION AND USED A REMOVAL TOOL TO REMOVE THE DAMAGED DEVICE AND THIS CAUSED SOME MINOR DAMAGE (BONE REMOVAL) TO THE VERTEBRA BEYOND WHAT IS CONSIDERED TRIVIAL. NO NEGATIVE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Vertebral Fracture

  MAUDE report 21606695 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT EXPERIENCED AN INFECTION IN THE LUMBAR SPINE REGION. THE SURGEON REMOVED THE DEVICE AS PART OF THE REVISION SURGERY AND THE FACILITY WOULD NOT ALLOW THE REMOVED DEVICE TO BE SENT TO THE MANUFACTURER DUE TO THE PRESENCE OF AN INFECTION.

  Patient problems: Post Operative Wound Infection

  MAUDE report 21594840 ↗

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