Intracept RLV 0055Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00852454006226), received between Dec 14, 2023 and Mar 6, 2026 — classified as 17 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (12 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 18, 2026.

Recalls naming this device

1. Apr 22, 2026Class IIOpen, Classified

   Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to severe infection.

   Z-2694-2026 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE INTRACEPT PROCEDURE, THE FIRST ABLATION AT L3 WAS COMPLETED WITHOUT ISSUE. THE SECOND LEVEL WAS THEN STARTED AT L4, AND ABLATION HAD BEEN UNDERWAY FOR LESS THAN TWO MINUTES WHEN THE PATIENT BEGAN TO ASPIRATE. THE PHYSICIAN IMMEDIATELY STOPPED THE ABLATION AND REMOVED THE INTRACEPT INSTRUMENTS. THE ANESTHESIA TEAM PROVIDED SUCTION TO CLEAR THE AIRWAY. THE PATIENT HAD BEEN UNDER MONITORED ANESTHESIA CARE (MAC) USING PROPOFOL AS THE SOLE SEDATIVE. THE PHYSICIAN DOES NOT BELIEVE THE ASPIRATION EVENT WAS CAUSED BY THE INTRACEPT DEVICE OR THE PROCEDURE ITSELF. WHEN EMERGENCY SERVICES ARRIVED, THE PATIENT WAS AWAKE, SPEAKING, AND BREATHING INDEPENDENTLY. THE CAUSE OF THE PATIENT'S COMPLICATIONS IS UNKNOWN. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE DEVICES WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Aspiration/Inhalation

  MAUDE report 24533638 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE, THE PATIENT HAD FLUIDS COMING OUT OF HIM. THE PATIENT WAS UNDER ANESTHESIA WHEN THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE DUE TO THE PATIENT ASPIRATING. AS A RESULT, 911 WAS CALLED FOR THE PATIENT. THE PHYSICIAN ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE OR THE PROCEDURE, AS THE PATIENT'S ISSUES DID NOT INVOLVE THE TOOLS OR THE INTRACEPT PROCEDURE. THE CAUSE OF THE PATIENT'S COMPLICATIONS AND THE PATIENT'S CURRENT STATUS IS UNKNOWN. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Aspiration/Inhalation; Fluid Discharge

  MAUDE report 24242801 ↗
• MalfunctionJan 9, 2026Material Fragmentation; Nonstandard Device; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE, UPON REMOVAL OF THE PROBE, CURVED CANNULA, AND INTRODUCER CANNULA, A PIECE OF THE CURVED CANNULA PEEK WAS SHEARED OFF. THE ISSUE OCCURRED AT THE FIRST LEVEL AFTER COMPLETION OF ABLATION AT THAT LEVEL AND IT WAS NOTED THAT HARD BONE WAS ENCOUNTERED. THE SHEARED PEEK FRAGMENT WAS LEFT BEHIND INSIDE THE PATIENT. IT IS UNKNOWN WHETHER THE DEVICE FRAGMENT IS CONTAINED INSIDE THE BONE AS IT WAS NOT VISIBLE ON THE X-RAY. ALL DEVICES USED DURING THE PROCEDURE WERE DISPOSED BY THE FACILITY AND WILL NOT BE RETURNED FOR DEVICE ANALYSIS.

  Patient problems: Foreign Body In Patient

  MAUDE report 24024250 ↗
• InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED BY THE PATIENT THAT THEY SUSTAINED INJURIES DUE TO THE DEVICE AND/OR PROCEDURE. NO FURTHER INFORMATION REGARDING THE EVENT OR DEVICE CAN BE OBTAINED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23951806 ↗
• InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE, THERE WAS A SLIP OF THE INTRODUCER CANNULA PRIOR TO TRAVERSING THE PEDICLE. THE PHYSICIAN NOTICED THAT THE INTRODUCER CANNULA JUMPED ANTERIORLY QUICKER THAN USUAL AND ON THE SUPERIOR BORDER OF THE PEDICLE. BLEEDING WAS CONTROLLED THROUGHOUT THE PROCEDURE AND DERMABOND WAS APPLIED FOR CLOSURE. HOWEVER, DURING THE SECOND PROCEDURE, THE PATIENT CONTINUED TO EXPERIENCE BLEEDING AND WAS TRANSPORTED TO THE EMERGENCY ROOM (ER). THE PHYSICIAN STATED THAT THE CAUSE OF THE BLEEDING WAS DUE TO A VESSEL NEAR OR INSIDE THE PEDICLE BEING SEVERED DURING THE PROCEDURE.ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT IS DOING WELL POSTOPERATIVELY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23950203 ↗
• MalfunctionNov 24, 2025Material Fragmentation; Nonstandard Device; Material Integrity Problem; Material Fragmentation; Nonstandard Device; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE THAT THE PHYSICIAN ENCOUNTERED HARD BONE AND WHILE MALLEATING THE BEVEL STYLET AND INTRODUCER CANNULA, PART OF THE BLUE PLASTIC BROKE OFF THE TOP OF THE BEVEL STYLET. THE BROKEN PIECE WAS NOT INSIDE THE PATIENT. THE PHYSICIAN SWITCHED TO A DIAMOND STYLET AND WHEN THE CURVED CANNULA ASSEMBLY WAS REMOVED, HE NOTICED THAT PART OF THE PEEK BROKE OFF THE DISTAL END. IT IS LIKELY THAT SOME OF THE PEEK WAS LEFT BEHIND INSIDE THE PATIENT. SINCE NO DEVICE FRAGMENTS WERE VISIBLE ON THE X-RAY, IT COULD NOT BE CONFIRMED WHETHER THERE WERE DEVICE FRAGMENTS CONTAINED INSIDE OR OUTSIDE THE BONE. THE PROCEDURE WAS COMPLETED AS USUAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 23640765 ↗
• InjuryNov 18, 2025Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INTRACEPT PROCEDURE WHERE UPON THE PHYSICIANS FIRST FEW TAPS OF THE MALLET, THE J-STYLET SHARPLY DOVE INFERIORLY. UPON RETRACTING THE J-STYLET AND REMOVAL FROM THE STRAIGHT CANNULA, THE PHYSICIAN NOTICED THAT A PIECE OF THE PEEK SHEATH HAD BEEN SHEARED OFF AND LIKELY REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS ABORTED FOR FURTHER EVALUATION OF THE PATIENT. THE PATIENT WAS THEN WOKEN UP AFTER THE PROCEDURE AND EXPERIENCED RADICULAR PAIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND HAD A MAGNETIC RESONANCE IMAGING (MRI) AND A COMPUTER TOMOGRAPHY (CT) SCAN PERFORMED. THE PATIENTS PAIN SEVERITY REMAINED HIGH. THE PHYSICIAN BELIEVES THAT THE CURVED CANNULA PEEK SHEATH IS IN THE SPINAL CANAL. THE PHYSICIAN REPORTED THAT THE NEUROSURGEON DECOMPRESSED THE NERVE WITH A LAMINECTOMY. THE PHYSICIAN VISUALIZED THE BREACH, BUT DID NOT FIND ANY SHEARED PEEK DEVICE FRAGMENTS, ONLY SOME BONE FRAGMENTS. THE PATIENT STATED THAT THEY WERE EXPERIENCING LESS PAIN AND THAT HER HIP PAIN IMPROVED. THE PATIENT ALSO REPORTED MOSTLY HAVING BACK PAIN. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND THEIR LEG PAIN IS GONE, HOWEVER, THE PATIENT CONTINUES TO HAVE

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 23586226 ↗
• MalfunctionOct 31, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INTERCEPT PROCEDURE AND WHEN THE CURVED CANNULA WAS REMOVED, THE DISTAL TIP WAS MISSING AND DAMAGED. IT WAS NOTED THAT THE PHYSICIAN ENCOUNTERED RESISTANCE DURING THE PROCEDURE AND A SMALL DEVICE FRAGMENT WAS LEFT INSIDE THE PATIENT. HOWEVER, IT WAS UNKNOWN WHETHER THE DEVICE FRAGMENT WAS LEFT INSIDE OR OUTSIDE THE BONE. THE PHYSICIAN MOVED TO THE OTHER SIDE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 23442250 ↗
• InjurySep 19, 2025Defective Device; Difficult to Advance; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Defective Device; Difficult to Advance; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE, THE HANDLE OF THE INTRODUCER CANNULA CRACKED APART AT THE SEAM AND THE TOOLS WERE UNABLE TO REACH THE ABLATION TARGET ZONE. IT WAS NOTED THAT THE PATIENT HAD VERY HARD BONE AND THE PHYSICIAN HAD TO MALLET MORE THAN USUAL DURING THE PROCEDURE. IN ADDITION, THERE WAS BENDING THAT WAS NOTED ON THE INTRACEPT ACCESS TOOLS. THE CURVED CANNULA ASSEMBLY WAS UNABLE TO REACH THE TARGET SAFELY AND THE PROCEDURE WAS ABORTED. NO HARM WAS CAUSED TO THE PATIENT AND THE CASE WILL BE RESCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23103242 ↗
• MalfunctionAug 29, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE, THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO TROUBLESHOOT HITTING THE TARGET BY REMOVING THE J-STYLET MULTIPLE TIMES TO INSERT THE PROBE. WHEN THE CURVED CANNULA WAS REMOVED, THE TIP OF THE PEEK WAS SHEARED OFF. IT COULD NOT BE CONFIRMED WHETHER THE DEVICE FRAGMENT WAS CONTAINED INSIDE OR OUTSIDE THE BONE. THE PROCEDURE WAS COMPLETED AS SCHEDULED AND THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22929344 ↗
• MalfunctionAug 25, 2025Device Dislodged or Dislocated; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE INTERCEPT PROCEDURE, THE PHYSICIAN ENCOUNTERED VERY HARD BONE. WHILE MALLETING THE INTRODUCER CANNULA WITH THE DIAMOND STYLET, THE STYLET KEPT POPPING UP FROM THE INTRODUCER CANNULA AND ENDED UP BREAKING. THE STYLET WOULD NO LONGER CLICK INTO THE INTRODUCER CANNULA. THE SAME ISSUE ALSO OCCURRED WITH THE BEVEL STYLET. IT WAS NOTED THAT ONE OF THE T-HANDLES ON THE INTRODUCER CANNULA STARTED SPLITTING APART. A NEW KIT WAS OPENED AND A NEW DIAMOND STYLET AND BEVEL STYLET WERE USED TO COMPLETE THE PROCEDURE. THE INTRODUCER CANNULA, DIAMOND STYLET, AND TWO CURVED CANNULAS WERE RETURNED FOR ANALYSIS. A VISUAL INSPECTION REVEALED THAT ONE INTRODUCER CANNULA HANDLE WAS SLIGHTLY SPLIT BETWEEN THE DARK AND LIGHT GRAY PLASTIC AND THE SECOND INTRODUCER CANNULA HANDLE LATCH WAS BROKEN. IT WAS FOUND THAT THE DIAMOND STYLET LATCH WAS BROKEN AND TWO CURVED CANNULA TIPS WERE SHEARED. THE BEVEL STYLET WAS NOT RETURNED FOR ANALYSIS. IT COULD NOT BE CONFIRMED IF ANY DEVICE FRAGMENTS WERE LEFT BEHIND INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22890322 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INTRACEPT PROCEDURE WHERE THE L5 LUMBAR VERTEBRAE AND S1 SACRAL VERTEBRAE WERE ACCESSED, AND THE TARGETS WERE REACHED SUCCESSFULLY. WHILE ACCESSING L5, THE PROVIDER NOTED HE WAS IN THE PEDICLE AND BASED ON IMAGING, IT WAS POSSIBLE HE WAS ACCESSING THE INFERIOR PORTION OF THE PEDICLE. AFTER THE PROCEDURE, THE PATIENT EXPERIENCED MINOR WEAKNESS IN THEIR RIGHT LEG. THE PATIENT ELECTED TO GO TO THE HOSPITAL FOR OBSERVATION DUE TO LACK OF SUPPORT AT HOME. THE PATIENT WAS RELEASED WITHIN TWENTY-FOUR HOURS. THE PATIENT WAS IN GOOD HEALTH AND DID NOT HAVE ANY FURTHER ISSUES. THE DEVICES WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Muscle Weakness/Atrophy; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 22868838 ↗
• MalfunctionJun 20, 2025Material Fragmentation; Nonstandard Device; Difficult to Remove; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Fragmentation; Nonstandard Device; Difficult to Remove; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE, THE J-STYLET WAS DIFFICULT TO REMOVE AFTER THE CHANNEL WAS CREATED WITH THE CURVED CANNULA ASSEMBLY. THE SHEATH WAS REMOVED TO REPOSITION THE DEVICE, HOWEVER, THE SHEATH SNAPPED OFF. IT IS UNKNOWN IF ANY DEVICE FRAGMENTS WERE LEFT BEHIND INSIDE THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE FRAGMENTS WERE LEFT INSIDE THE PATIENT, AND THEY WERE CONTAINED INSIDE THE BONE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22302283 ↗
• MalfunctionJun 11, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE INTRACEPT PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE THE J-STYLET. THE PHYSICIAN WAS ADVISED TO RE-DOCK AND RE-ADVANCE THE J-STYLET DUE TO POSITIONING. UPON REMOVAL OF THE J-STYLET, THE DISTAL TIP OF THE CURVED CANNULA WAS SHEARED AND BROKEN OFF. IT WAS UNKNOWN IF ANY BROKEN DEVICE FRAGMENTS WERE LEFT INSIDE THE PATIENT AS IT WAS NOT DETECTABLE ON FLUOROSCOPY. NO DEVICES ARE AVAILABLE TO BE RETURNED FOR DEVICE ANALYSIS.

  Patient problems: Foreign Body In Patient

  MAUDE report 22190306 ↗
• MalfunctionJun 5, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE, THE TIP OF THE CURVED CANNULA PEEK BROKE OFF WHILE IT WAS BEING INSERTED INTO THE PATIENT. HARD BONE WAS ENCOUNTERED AND ABOUT ONE TO TWO LEVELS WERE COMPLETED PRIOR TO THE ISSUE OCCURRING. THE BROKEN DEVICE FRAGMENT COULD NOT BE FOUND ANYWHERE ON THE CURVED CANNULA AND IT WAS DETERMINED THAT THE BROKEN FRAGMENT WAS LEFT INSIDE THE PATIENT. IT COULD NOT BE CONFIRMED WHETHER THE DEVICE FRAGMENT WAS CONTAINED INSIDE THE BONE OR OUTSIDE THE BONE. THE PROCEDURE WAS COMPLETED AS SCHEDULED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22155434 ↗
• InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER SUCCESSFUL COMPLETION OF THE INTRACEPT PROCEDURE ON THE L5 LUMBAR VERTEBRAE, THE PATIENTS ELECTROCARDIOGRAM (EKG) LOOKED ABNORMAL TO THE STAFF. THE PATIENT WAS UNDER MONITORED ANESTHESIA CARE (MAC) SEDATION AND WAS HAVING DIFFICULTY LYING ON THE BED FOR AN EXTENDED PERIOD OF TIME DUE TO THEIR WEIGHT AND SIZE. THE PATIENT WAS TAKEN TO THE HOSPITAL FOR CARDIAC EVALUATION AS A PRECAUTION. THERE WERE NO REPORTED DEVICE ISSUES. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 22144298 ↗
• InjuryMay 23, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE WHEN THE PHYSICIAN WAS MALLEATING, THE STRAIGHT STYLET BECAME BENT AND KINKED. IT WAS NOTED THAT HARD BONE WAS ENCOUNTERED AND ONLY THE FIRST LEVEL WAS ATTEMPTED. AS A RESULT, THE STRAIGHT STYLET WAS REMOVED AND THE PHYSICIAN NOTICED AN UNUSUAL AMOUNT OF BLEEDING. DUE TO THE EXCESSIVE BLOOD LOSS, THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE. PRESSURE WAS APPLIED TO THE INCISION UNTIL THE BLEEDING STOPPED, AND SKIN GLUE WAS USED TO CLOSE THE INCISION. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS DOING WELL POSTOPERATIVELY. ALL PRODUCTS WERE DISPOSED BY THE MEDICAL FACILITY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22080876 ↗
• InjuryApr 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PATIENT WAS SEDATED AND THE PATIENTS BREATHING BECAME OBSTRUCTED. THE PATIENT HAD TO BE FLIPPED ON THE TABLE. AS A RESULT, THE PROCEDURE WAS ABORTED. THE PATIENT WAS STABLE POSTOPERATIVELY.

  Patient problems: Respiratory Insufficiency

  MAUDE report 21845445 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SEDATED AND EXPERIENCED A DESATURATION EVENT DURING A PROCEDURE. THE PATIENT WAS SUBSEQUENTLY INTUBATED. ZERO LEVELS WERE COMPLETED BEFORE THE ISSUE AROSE AND THE PEDICLE WAS STILL BEING TRAVERSED. ABLATION WAS NOT STARTED BEFORE THIS EVENT OCCURRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT IS DOING WELL POSTOPERATIVELY WITH NO COMPLICATIONS.

  Patient problems: Respiratory Insufficiency

  MAUDE report 21735549 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHILE DOCKING THE DIAMOND STYLET IN S1, THE ANESTHESIA PROVIDER HAD A DIFFICULT TIME MAINTAINING THE PATIENTS AIRWAY. THE PATIENT'S AIRWAY BECAME OBSTRUCTED AND THE PATIENT HAD A HARD TIME MAINTAINING AN OXYGEN SATURATION OF OVER EIGHTY PERCENT. THE PHYSICIAN CHOSE TO ABORT THE PROCEDURE AND NO LEVELS WERE TREATED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS SEDATED FOR THE PROCEDURE AND THE PATIENT WAS PLACED IN A SUPINE POSITION TO TREAT THE PATIENTS OXYGEN SATURATION ISSUES.

  Patient problems: Respiratory Insufficiency

  MAUDE report 21735505 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ANESTHESIA ISSUE DURING THE PROCEDURE. THE PATIENT NEEDED TO BE FLIPPED SUPINE AND ASSESSED. EMERGENCY MEDICAL SERVICE (EMS) WAS CALLED PER HOSPITAL PROTOCOL. THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE DUE TO THE ANESTHESIA ISSUE AND NO LEVELS WERE COMPLETED. IT WAS NOTED THAT THE PATIENT WAS SEDATED DURING THE PROCEDURE AND THE DEVICES WERE DISCARDED BY THE HOSPITAL.

  Patient problems: Insufficient Information

  MAUDE report 21684714 ↗
• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE, THE PATIENT VOMITED AFTER THE PHYSICIAN ACCESSED THE FIRST PEDICLE. THE PATIENT HAD TO BE FLIPPED SUPINE TO RE-ESTABLISH AIRWAY AND THE PHYSICIAN CANCELLED THE PROCEDURE. THE PATIENT WAS SEDATED AND THERE WERE NO REPORTED DEVICE ISSUES. THE PATIENT WAS DOING WELL POSTOPERATIVELY. APPROXIMATELY TWO WEEKS AFTER THE CANCELLED PROCEDURE, THE PATIENT UNDERWENT ANOTHER INTRACEPT PROCEDURE AND IT WAS COMPLETED SUCCESSFULLY.

  Patient problems: Vomiting

  MAUDE report 21633236 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PATIENT WAS INTUBATED AND FLIPPED PRONE, THEY HAD AN ANESTHESIA ISSUE. THE PATIENT WAS FLIPPED SUPINE AND EXTUBATED. THE PATIENT WAS AWAKE AND ALERT AND TAKEN TO THE POST-ANESTHESIA CARE UNIT (PACU). EMERGENCY MEDICAL SERVICES (EMS) WAS CALLED TO TAKE THE PATIENT TO THE HOSPITAL PER MEDICAL FACILITY PROTOCOL. NO PRODUCT HAD BEEN OPENED YET FOR THIS PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 21553511 ↗
• MalfunctionMar 4, 2025Material Fragmentation; Adverse Event Without Identified Device or Use Problem; Material Fragmentation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PHYSICIAN ENCOUNTERED HARD BONE DURING THE PROCEDURE. FOR EACH LEVEL THAT WAS ACCESSED, THE CURVED CANNULA PEEK CAME OUT KINKED ON THE BOTTOM. L5 HAD TO BE ACCESSED ON BOTH SIDES DUE TO HARD BONE AND ALL THREE CURVED CANNULAS WERE SHEARED DUE TO HARD BONE AT THE PREVIOUS THREE LEVELS. IN ADDITION, THE LATCH BROKE OFF THE CURVED CANNULA ASSEMBLY ON THE FOURTH PEDICLE ACCESS. AN X-RAY WAS PERFORMED, BUT IT COULD NOT BE CONFIRMED WHETHER OR NOT THE SHEARED PEEK WAS LEFT BEHIND INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21521309 ↗
• MalfunctionFeb 12, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN INTERCEPT PROCEDURE THE PEEK MATERIAL OF THE CURVED CANNULA SHEARED OFF INSIDE THE PATIENT'S L5 VERTEBRAL BODY. THE PHYSICIAN TRIED TO ACCESS THE OTHER SIDE OF L5 BUT WAS UNSUCCESSFUL. THE DECISION WAS MADE TO ABORT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21367628 ↗