Intracept RLV 0045Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00852454006301), received between Jan 5, 2024 and Aug 4, 2026 — classified as 1 death, 7 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (9 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2026Nonstandard Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50136388 ↗
• InjuryJul 21, 2026Material Fragmentation; Difficult to Remove; Material Integrity Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEVEL THREE INTRACEPT PROCEDURE AND THE J-STYLET AND CURVED CANNULA PEEK BROKE OFF INTO THE PEDICLE AND VERTEBRA DURING THE PROCEDURE. THE PROCEDURE WAS PERFORMED WITHOUT DIFFICULTY, HOWEVER, WHEN THE J-STYLET WAS REMOVED FROM THE PATIENT, THE CURVED CANNULA PEEK WAS EMBEDDED IN THE L5 VERTEBRAL BODY AND RIGHT L5 PEDICLE. THE PATIENT REPORTED EXPERIENCING A NEW PAIN SYNDROME SINCE THE PROCEDURE. THE PATIENT FEELS THAT THE LEFT-SIDED SYMPTOMS HAVE IMPROVED. THE PHYSICIAN STATED THAT THE MAJORITY OF THE PATIENTS RIGHT SIDED LOW BACK, BUTTOCK AND THIGH PAIN IS SECONDARY TO HER ACUTE RIGHT L5 TRANSVERSE PROCESS FRACTURE. THE PATIENT CONTINUES TO HAVE BACK PAIN FROM THE INCISION SITE BUT IT SEEMS TO BE IMPROVING WITH TIME. THE PATIENT IS EXPERIENCING PAIN SHOOTING DOWN HER RIGHT LEG THAT SEEMS TO BE NEW AND DIFFERENT FROM HER REGULAR BACK PAIN. THE PAIN IS INTERMITTENT IN NATURE AND IT IS A SHARP, STABBING SENSATION THAT RADIATES ALONG THE POSTEROLATERAL THIGH TO THE LEVEL OF THE CALF. THE PATIENT RATES HER PAIN AS MODERATE TO SEVERE IN INTENSITY. AN X-RAY OF THE LUMBAR SPINE WAS PERFORMED AND CONFIRMED THE DEVICE FRAGMENT FROM THE INTRACEPT

  Patient problems: Anxiety; Bone Fracture(s); Foreign Body In Patient; Inappropriate Device Stimulation of Tissue; Inflammation; Pain

  MAUDE report 25899509 ↗
• MalfunctionJun 2, 2026Material Fragmentation; Nonstandard Device; Material Integrity Problem

  IT WAS REPORTED THAT AN INTRACEPT CURVED CANNULA WAS RETURNED FOR AN UNKNOWN REASON. A VISUAL INSPECTION REVEALED THAT THE CURVED CANNULA HANDLE AND SHAFT TIP WERE BROKEN. THE J-STYLET WAS TESTED WITH A KNOWN GOOD CURVED CANNULA AND A KNOWN GOOD INTRODUCER CANNULA. IT WAS FOUND THAT THE J-STYLET LACKS ANY EXTREME RESISTANCE DURING THE FUNCTIONAL TEST. A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICES WERE USED PER THE INSTRUCTIONS FOR USE (IFU) PRODUCT LABEL. A LABELING REVIEW DID NOT REVEAL ANY ANOMALIES AS IT STATES THAT AS WITH ANY SURGICAL INSTRUMENT, CAREFUL ATTENTION MUST BE EXERCISED TO ENSURE THAT EXCESSIVE FORCE IS NOT PLACED ON THE INSTRUMENTS OR PROBE. EXCESSIVE FORCE CAN RESULT IN PRODUCT FAILURE. A LABELING REVIEW ALSO STATES THAT IN THE EVENT OF INADVERTENT ADVANCEMENT OF THE INTRODUCER CANNULA DURING DEPLOYMENT OF THE CURVED CANNULA ASSEMBLY, CARE MUST BE TAKEN TO PREVENT POTENTIAL FURTHER DEVICE DAMAGE. THIS CAN OCCUR IF MALLET STRIKES CONTINUE TO BE DELIVERED WHEN THE GEAR WHEEL IS IN CONTACT WITH THE INTRODUCER CANNULA. THIS SCENARIO CAN CREATE A CONDITION IN WHICH THE INTRODUCER CANNULA ADVANCES ALONG ITS STRAIGHT TRAJECTORY, WHILE THE CURVED CANNULA IS HELD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25366973 ↗
• MalfunctionApr 28, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT THE OUTER PACKAGING OF THIS ACCESS ACCESSORY KIT WAS OPENED BY A SCRUB TECH. VISUAL EXAMINATION NOTED A HAIR WITHIN THE STERILE PACKAGING. A NEW KIT WAS OPENED TO COMPLETE THE PROCEDURE. THIS KIT AND ITS PACKAGING WERE DISCARDED AND WERE NOT RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25017890 ↗
• MalfunctionJan 23, 2026Material Fragmentation; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE, THE PHYSICIAN ENCOUNTERED VERY HARD BONE AND IT WAS DIFFICULT TO GET THE STYLET INTO THE CANNULA. WHEN THE PHYSICIAN ATTEMPTED TO TAKE EVERYTHING OUT, HE NOTICED THAT THE PEEK OF THE CURVED CANNULA WAS MISSING AND THE CURVED CANNULA ASSEMBLY WAS NOT SEAMLESSLY FITTING TOGETHER. IT WAS NOTED THAT A SMALL PART OF THE PEEK WAS LEFT BEHIND INSIDE THE PATIENT AND IT IS UNKNOWN IF IT WAS LEFT INSIDE THE BONE OR OUTSIDE THE BONE. THE ISSUE AROSE ON THE FIRST LEVEL AND THERE WERE NO PATIENT COMPLICATIONS. THE DEVICES WERE DISCARDED BY THE FACILITY AND WILL NOT BE RETURNED FOR DEVICE ANALYSIS.

  Patient problems: Foreign Body In Patient

  MAUDE report 24171707 ↗
• MalfunctionDec 19, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE, THERE WERE ISSUES WITH INSERTING THE PROBE INSIDE THE CURVED CANNULA. IT WAS NOTICED THAT THE CURVED CANNULA HAD A SHEARED PEEK AT THE DISTAL TIP. AN ADDITIONAL INTRACEPT KIT WAS OPENED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE CURVED CANNULA WAS FLUSHED OUT, BUT THE SHEARED PEAK DID NOT COME OUT. ONLY CLOTTED BLOOD CAME OUT, WHICH WAS NOTED AS NORMAL FOR THIS PROCEDURE. IT IS UNKNOWN IF THE SHEARED PEEK WAS STILL WITHIN THE BONE OR INSIDE THE PATIENT. THE SHEARED PEEK WAS NOT SEEN ON ANY IMAGING THAT WAS TAKEN DURING THE PROCEDURE. IN ADDITION, FOUR LEVELS WERE COMPLETED BEFORE THE ISSUE OCCURRED AND IT WAS NOTED THAT SOME HARD BONE WAS ENCOUNTERED DURING THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23855904 ↗
• DeathDec 9, 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 patients pulse and blood pressure dropped after the first vertebral level was completed. The patient stopped breathing and the procedure was immediately aborted. The patient was turned into a supine position, intubated, and chest compressions were performed to restore the patients pulse and blood pressure. The patient was given medication to reverse anesthesia and raise their heart rate. The patient was unconscious following the procedure and the medical team assessed that the patients poor lung health and medical history of respiratory depression and hypoxia were believed to be related to the patients complications. The patient was successfully stabilized and transferred to the intensive care unit (ICU). After the patient was admitted to the ICU, the patient did not regain consciousness. The patient exhibited minimal brainwave activity and was thought to have hypoxic brain damage. The patient was taken off life support and passed away. There were no reported device issues.Additional information was received that an autopsy was not performed on this patient. The patient's pre-existing poor medical condition is believed to have

  Patient problems: Arrhythmia; Bradycardia; Hypoxia; Low Blood Pressure/ Hypotension

  MAUDE report 23762848 ↗
• MalfunctionNov 7, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A CLINICAL STUDY PATIENT EXPERIENCED THE PLASTIC TIP OF THE PEEK SHEATH ON THE CURVED CANNULA BREAKING DURING AN INTRACEPT PROCEDURE. THE DEVICE FRAGMENT WAS LEFT INSIDE THE PATIENT. IT IS UNKNOWN WHETHER THE DEVICE FRAGMENT WAS CONTAINED INSIDE OR OUTSIDE THE BONE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23503805 ↗
• InjuryAug 8, 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'S VITAL SIGNS DROPPED WHEN THE S1 SACRAL VERTEBRAE WAS ACCESSED THROUGH THE PEDICLE. THE J-STYLET WAS ADVANCED ABOUT HALFWAY THROUGH THE THREADS WHEN THE PATIENTS VITAL SIGNS DROPPED. AS A RESULT, THE EVENT PROMPTED THE CRASH CART TO BE CALLED INTO THE ROOM. ABLATION WAS NOT ATTEMPTED AND THE PROCEDURE WAS ABORTED. IN ADDITION, THE BOSTON SCIENTIFIC SALES REPRESENTATIVE STATED THAT THE PATIENT WAS ON THE FLOOR. NO PRODUCTS WILL BE RETURNED AS THEY WERE DISCARDED BY THE FACILITY. ADDITIONAL INFORMATION WAS RECEIVED THAT IV SEDATION WAS USED DURING THE PROCEDURE AND THE PATIENT IS DOING WELL. THE PHYSICIAN ASSESSED THE PATIENTS DROPPING VITAL SIGNS AS UNRELATED TO THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT IV SEDATION WAS USED DURING THE PROCEDURE AND THE PATIENT IS DOING WELL. THE PHYSICIAN ASSESSED THE PATIENT'S DROPPING VITAL SIGNS AS UNRELATED TO THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 22758767 ↗
• MalfunctionJul 1, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE, THE PROBE EXHIBITED HIGH IMPEDANCE AND IT WAS FOUND THAT THE CURVED CANNULA HAD A SHEARED PEEK AT THE DISTAL TIP. THE L5 LUMBAR VERTEBRAE WAS ABORTED ON THE LEFT SIDE. ABLATION ON THE RIGHT SIDE WAS SUCCESSFUL. THE PHYSICIAN STATED THAT IT IS MORE THAN LIKELY SOME OF THE CURVED CANNULA PEEK SHEARED OFF AND IS STILL IN THE LEFT L5 LUMBAR VERTEBRAL BODY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 22373413 ↗
• MalfunctionJun 4, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DURING THE INTRACEPT PROCEDURE, THE PHYSICIAN ENCOUNTERED HARD BONE. WHEN THE PHYSICIAN REMOVED THE CURVED CANNULA, HE NOTICED THAT THE TIP WAS BROKEN. THE BROKEN DEVICE FRAGMENT WAS UNABLE TO BE RETRIEVED DURING THE PROCEDURE, AND IT COULD NOT BE CONFIRMED THAT THE DEVICE FRAGMENT WAS CONTAINED INSIDE THE BONE VIA FLUOROSCOPY. AN ADDITIONAL KIT WAS OPENED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED AIR EMBOLISM DURING THE PROCEDURE.

  Patient problems: Air Embolism; Foreign Body In Patient

  MAUDE report 22146967 ↗
• MalfunctionJun 3, 2025Difficult to Remove; Defective Device; Difficult to Remove; Defective Device

  IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE, HARD BONE WAS ENCOUNTERED AT THE L5 LUMBAR VERTEBRAE. DURING THE DEPLOYMENT OF THE CURVED CANNULA ASSEMBLY, THE INSTRUMENT APPEARED TO TURN POSTERIOR IN THE VERTEBRAL BONE. THE PHYSICIAN ATTEMPTED TO REMOVE THE CURVED CANNULA ASSEMBLY AND GO BACK IN WITH A STRAIGHT STYLET. HOWEVER, IT WAS DIFFICULT FOR THE PHYSICIAN TO PULL OUT THE CURVED CANNULA ASSEMBLY. AFTER A LOT OF FORCE, THE CURVED CANNULA ASSEMBLY WAS EVENTUALLY REMOVED. THE END OF THE CURVED CANNULA APPEARED TO BE A LITTLE BEATEN UP AND THE PHYSICIAN DECIDED NOT TO CONTINUE USING THE ORIGINAL CURVED CANNULA. AFTER DRIVING DEEPER INTO THE VERTEBRAL BONE USING THE STRAIGHT STYLET, THE SECOND CURVED CANNULA ASSEMBLY WAS DEPLOYED. THE PHYSICIAN WAS NOT ABLE TO ADVANCE THE PROBE COMPLETELY ACROSS THE SPINOUS PROCESS, SO THE PHYSICIAN ATTEMPTED TO REMOVE THE PROBE. THE PROBE APPEARED TO BE STUCK BUT WAS ABLE TO BE COMPLETELY REMOVED BY THE PHYSICIAN. THE GENERATOR DISPLAYED AN IMPEDANCE ERROR WHEN THE PHYSICIAN ATTEMPTED TO START A BURN. THE ISSUE WAS RESOLVED WITH A NEW PROBE AND THE CASE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS DOING WELL POSTOPERATIVELY. TWO CURVED CANNUL

  Patient problems: Foreign Body In Patient

  MAUDE report 22135383 ↗
• MalfunctionJun 3, 2025Difficult to Remove; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE INTRACEPT PROCEDURE, THE PHYSICIAN HAD DIFFICULTIES REMOVING THE J-STYLET FROM THE CURVED CANNULA DUE TO VERY HARD BONE. THE PHYSICIAN BEGAN TO TWIST AND PULL EXTREMELY HARD WHILE HOLDING BOTH THE J-STYLET AND THE CURVED CANNULA. THIS CAUSED THE TOP OF THE CURVED CANNULA TO SNAP OFF WHEN THE J-STYLET WAS REMOVED. HOWEVER, THIS DID NOT CAUSE ANY ISSUES WITH COMPLETING THE LESION AND THE PHYSICIAN STATED THAT THE INSTRUMENT BROKE DUE TO HIM PUTTING A TREMENDOUS AMOUNT OF FORCE ON IT. THE BROKEN CURVED CANNULA WAS RETURNED AND ANALYZED. VISUAL INSPECTION REVEALED THAT THE CURVED CANNULA HANDLE WAS BROKEN OFF FROM THE SCREW THREADS AND THE SHAFT TIP WAS SHEARED. IT COULD NOT BE CONFIRMED IF ANY DEVICE FRAGMENTS WERE LEFT BEHIND INSIDE THE PATIENT AND WHETHER OR NOT THEY WERE CONTAINED INSIDE THE BONE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22133448 ↗
• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE INTRACEPT PROCEDURE, THE PATIENT ASPIRATED AFTER EIGHT MINUTES INTO ABLATION OF THE L5 LUMBAR VERTEBRAE AND THE PROCEDURE WAS ABORTED. IT WAS NOTED THAT LOCAL ANESTHESIA WAS USED WITH MODERATE SEDATION. THE PATIENT LEFT THE ROOM FEELING WELL WAS NOT INTUBATED. THE PATIENT WAS SENT FOR A CHEST X-RAY AND NO ISSUES WERE FOUND. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE DEVICES WERE DISCARDED BY THE MEDICAL FACILITY. THE PHYSICIAN ASSESSED THE EVENT AS NOT CAUSED BY THE DEVICE OR PROCEDURE.

  Patient problems: Aspiration/Inhalation

  MAUDE report 22081096 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INTERCEPT PROCEDURE, THE PATIENT EXPERIENCED A SUPERFICIAL FORMING HEMATOMA THAT RESPONDED TO PRESSURE. THE PATIENT HAD SKIN INCISIONS THAT BLED QUITE A BIT, BUT THE PATIENT WAS DISCHARGED STABLE. UPON RETURNING HOME, THE PATIENT BECAME LIGHTHEADED WHILE WALKING TO THE FRONT DOOR AND FELL TO HIS KNEE. THE PATIENT WAS HYPOTENSIVE WHEN EMERGENCY MEDICAL SERVICES (EMS) ARRIVED. THE PATIENT WAS TAKEN TO THE EMERGENCY DEPARTMENT (ED) AND WAS DIAGNOSED WITH A FEMORAL FRACTURE AND HAD A LOW BLOOD COUNT. A CT (COMPUTED TOMOGRAPHY) ABDOMEN SCAN REVEALED A LARGE LEFT RETROPERITONEAL HEMATOMA WITHOUT ACTIVE BLEEDING. THE PATIENT WAS TREATED WITH A TRANSFUSION AND A SERIAL CT SCAN SHOWED A RESOLVING HEMATOMA. THE PATIENT WAS DISCHARGED STABLE.

  Patient problems: Fall; Hematoma; Hemorrhage/Blood Loss/Bleeding; Limb Fracture; Low Blood Pressure/ Hypotension; Presyncope

  MAUDE report 21978657 ↗
• InjuryApr 14, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE AND THE PHYSICIAN NOTICED THAT THE PATIENT HAD HYPER-SCLEROTIC BONE, WHICH MADE IT DIFFICULT TO INSERT THE INSTRUMENTS. THE PHYSICIAN MADE ATTEMPTS TO INSERT THE ABLATION TOOL AND X-RAYS WERE CONTINUOUSLY TAKEN THROUGHOUT THE PROCEDURE. THE PHYSICIAN NOTICED THAT A PIECE OF THE J-STYLET HAD BROKEN OFF INSIDE THE PATIENT ALONG WITH A PORTION OF THE GUIDEWIRE CANNULA AND THE PROCEDURE WAS ABORTED. X-RAYS WERE TAKEN TO CONFIRM THE BROKEN FRAGMENT WAS IN THE VERTEBRAL BODY AND A COMPUTED TOMOGRAPHY (CT) LUMBAR SPINE SCAN WITHOUT CONTRAST WAS ORDERED POSTOP. NO LEVELS WERE TREATED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21837299 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA WHILE THE PHYSICIAN WAS ACCESSING THE VERTEBRAL BODY. THE PATIENT WAS SEDATED USING GENERAL ANESTHESIA AND NO ABLATION WAS PERFORMED. AS A RESULT, THE PROCEDURE WAS ABORTED. MEDICAL INTERVENTION WAS PERFORMED FOR THE PATIENTS BRADYCARDIA, HOWEVER, NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE PATIENT IS DOING WELL POSTOPERATIVELY.

  Patient problems: Bradycardia

  MAUDE report 21769810 ↗
• MalfunctionMar 3, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A STYLET WITH A SHEATH WAS USED DURING A PROCEDURE. THE STYLET WAS REMOVED FROM THE PATIENTS BACK AND THE SHEATH WAS MISSING APPROXIMATELY A CENTIMETER IN LENGTH. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 21511397 ↗
• MalfunctionMar 3, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A STYLET WITH A SHEATH WAS USED DURING A PROCEDURE. THE STYLET WAS REMOVED FROM THE PATIENTS BACK AND THE SHEATH WAS MISSING APPROXIMATELY A CENTIMETER IN LENGTH. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 21511303 ↗
• MalfunctionFeb 12, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN INTERCEPT PROCEDURE WHILE THE PHYSICIAN HAD DIFFICULTY REMOVING THE J-STYLET. THE PHYSICIAN TRIED TO PRY AND RATCHET THE J-STYLET OUT BUT EVENTUALLY REMOVED THE ASSEMBLY WITH THE CURVED CANNULA. WHEN THE ENTIRE ASSEMBLY WAS REMOVED IT WAS NOTICED THAT 2-3MM OF PEEK MATERIAL WAS SHEARED OFF FROM THE CURVED CANNULA INSIDE THE PATIENT. BASED ON THE AVAILABLE INFORMATION, BSC COULD NOT CONFIRM THE LOCATION OF THE DEVICE FRAGMENT. IT WAS NOTED THAT THE PATIENT HAD HARD BONE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21366191 ↗
• MalfunctionFeb 12, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE THAT TWO CURVED CANNULAS WERE DAMAGED AT THE DISTAL TIP. THE PEEK MATERIAL FROM THE CURVED CANNULAS SHEARED AND WAS LEFT INSIDE THE PATIENT. IT WAS NOTED THAT THE PATIENT HAD HARD BONE. BASED ON THE AVAILABLE INFORMATION, BSC COULD NOT CONFIRM THE LOCATION OF THE DEVICE FRAGMENT. THE PROCEDURE WAS COMPLETED WITH ADDITIONAL INSTRUMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21366147 ↗
• MalfunctionFeb 12, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE, THE INTRODUCER CANNULA BROKE APART AND DISLODGED FROM THE BONE. IT WAS NOTED THAT THE PATIENT HAD EXTREMELY HARD BONE. THE PHYSICIAN WAS ABLE TO REMOVE THE INTRODUCER CANNULA WITH PLIERS. UPON REMOVAL OF THE INTRODUCER CANNULA, IT WAS NOTICED THAT THE DISTAL END OF THE CURVED CANNULA WAS CRACKED AND SHEARED OFF. APPROXIMATELY 2-3CM OF THE CURVED CANNULAS DISTAL TIP IS WAS MISSING. BASED ON THE AVAILABLE INFORMATION, BSC COULD NOT CONFIRM THE LOCATION OF THE DEVICE FRAGMENT. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21365416 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  J-STYLET INSTRUMENT BROKEN OFF OUTSIDE THE VERTEBRAL BODY. PHYSICIAN OBTAINED AN ORTHOPEDIC CONSULT AND THE SURGEON WAS AFRAID THE BROKEN PIECE WAS TOO FAR ANTERIOR TO RETRIEVE SAFELY. HE WAS CONCERNED ABOUT VASCULAR DAMAGE TRYING TO RETRIEVE IT. HE SUGGESTED A CT SCAN AND THEN A VASCULAR SURGERY CONSULT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18451743 ↗