Intracept FG 0060Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00852454006189), received between Jun 18, 2022 and Feb 12, 2025 — classified as 9 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (3 reports).

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2025Material Fragmentation; Difficult to Remove; Material Fragmentation; Difficult to Remove

  IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE, THE PROCEDURE FACED ISSUES WITH HIGH IMPEDANCE ON THE ORIGINAL PROBE AT THE L5 VERTEBRAL BODY ON BOTH SIDES. THE PROBE WAS SWITCHED OUT WITH A NEW ONE. DESPITE CLEARING THE TRACT AND USING A NEW PROBE THE HIGH IMPEDANCES OCCURRED AGAIN BUT ON THE RIGHT SIDE OF L5. THE CURVED CANNULA ALSO BECAME STUCK IN L5, REQUIRING FORCE AND TWISTING IN ORDER TO REMOVE. THE PATIENT'S BONE WAS NOTABLY HARD. THE PEEK MATERIAL OF THE CURVED CANNULA SHEARED OFF IN THE LEFT SIDE OF L5. A NEW CURVED CANNULA WAS USED TO ACCESS THE RIGHT SIDE L5, IT ALSO SEEMED STUCK AND EVENTUALLY BROKE AT THE PROXIMAL END BUT WAS FULLY RETRIEVED WITH HEMOSTATS. THE PATIENT'S BONE ON THIS SIDE WAS NOT AS HARD BUT DENSE. THERE WERE NO DEVICE FRAGMENTS LEFT INSIDE THE PATIENT. DUE TO THESE COMPLICATIONS, L5 WAS NOT ABLATED, AND L4 WAS NOT ATTEMPTED. THE PROCEDURE WAS ABORTED. THE PATIENT HAD NO REPORTED COMPLAINTS BEFORE DISCHARGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21368070 ↗
• MalfunctionFeb 12, 2025Component Missing; Incomplete or Missing Packaging; Component Missing; Incomplete or Missing Packaging

  IT WAS REPORTED THAT DURING AN INTERCEPT PROCEDURE THE PHYSICIAN DISCOVERED THAT THE INSTRUMENT KIT WAS MISSING A STRAIGHT STYLET. ANOTHER INSTRUMENT KIT WAS OPENED, WHERE THE STRAIGHT STYLET WITHIN THE KIT DID NOT HAVE A RADIO OPAQUE MARKER. THE PATIENT EXPERIENCED AN AIRWAY AND BLOOD PRESSURE ISSUE DURING THE PROCEDURE. THE PHYSICIAN DECIDED THAT DUE TO THE PATIENT HEALTH ISSUES AND INSTRUMENT ISSUES TO ABORT THE PROCEDURE.

  Patient problems: Airway Obstruction; Low Blood Pressure/ Hypotension

  MAUDE report 21367756 ↗
• MalfunctionFeb 12, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE THE PHYSICIAN ENCOUNTERED HARD BONE CAUSING THE CURVED CANNULA TO GET STUCK. WHEN THE PHYSICIAN PULLED THE INSTRUMENT AGAIN, A PIECE OF THE DISTAL END OF THE CURVED CANNULA WAS MISSING. BASED ON THE AVAILABLE INFORMATION, BSC COULD NOT CONFIRM THE LOCATION OF THE DEVICE FRAGMENT. THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21366122 ↗
• MalfunctionFeb 12, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE THE PHYSICIAN ENCOUNTERED HARD BONE AND WHILE MALLETING CAUSED THE PEEK MATERIAL OF THE CURVED CANNULA TO SHEAR OFF INTO THE PATIENT. BASED ON THE AVAILABLE INFORMATION, BSC COULD NOT CONFIRM THE LOCATION OF THE DEVICE FRAGMENT. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21364971 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE COMPLETED SUCCESSFULLY BUT PATIENT HAD POST-OP VCF. SURGICAL INTERVENTION REQUIRED - KYPHOPLASTY PERFORMED AT L5.

  Patient problems: Bone Fracture(s); Spinal Column Injury; Vertebral Fracture

  MAUDE report 18975830 ↗
• InjurySep 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE COMPLETED. APPROXIMATELY, 1 CM + OF PEEK WAS LEFT IN THE PATIENT. PATIENT FELT GOOD IN POST OP AND WAS RELEASED HOME WITHOUT INCIDENT

  Patient problems: Foreign Body In Patient

  MAUDE report 17783302 ↗
• InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN TREATED L1-L3. THE PATIENT WAS IN EXTREME PAIN POST-OP AND FAINTED UPON SITTING UP BUT WAS CONSCIOUS. PATIENT'S BP WAS ALSO LOW, AND PHYSICIAN DECIDED TO SEND PATIENT TO THE HOSPITAL. THE PATIENT WAS DIAGNOSED WITH A RETROPERITONEAL HEMATOMA. NO SURGERY WAS NEEDED.

  Patient problems: Hematoma

  MAUDE report 15348913 ↗
• InjuryJun 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A L2 COMPRESSION FRACTURE 294 DAYS POST-OP. PATIENT WAS SUBSEQUENTLY TREATED WITH A L2 VERTEBROPLASTY/NO TERIPARATIDE. INTRACEPT TREATMENT OCCURRED ON L2-S1, 5 LEVELS.

  Patient problems: Bone Fracture(s); Spinal Column Injury; Vertebral Fracture

  MAUDE report 14740037 ↗
• InjuryJun 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A L2 COMPRESSION FRACTURE 19 DAYS POST-OP. PATIENT WAS SUBSEQUENTLY TREATED WITH A L2 VERTEBROPLASTY//NO TERIPARATIDE. INTRACEPT TREATMENT OCCURRED ON L2-S1, 5 LEVELS.

  Patient problems: Bone Fracture(s); Spinal Column Injury; Vertebral Fracture

  MAUDE report 14740036 ↗
• InjuryJun 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A L5 COMPRESSION FRACTURE 69 DAYS POST-OP. PATIENT WAS SUBSEQUENTLY TREATED WITH A L5 VERTEBROPLASTY/NO TERIPARATIDE. INTRACEPT TREATMENT OCCURRED ON L2-S1, 5 LEVELS.

  Patient problems: Bone Fracture(s); Spinal Column Injury; Vertebral Fracture

  MAUDE report 14740035 ↗
• InjuryJun 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A L2 COMPRESSION FRACTURE 14 DAYS POST-OP. PATIENT WAS SUBSEQUENTLY TREATED WITH A L2 VERTEBROPLASTY/ABALOPARATIDE. INTERCEPT TREATMENT OCCURRED ON L2-S1, 5 LEVELS.

  Patient problems: Bone Fracture(s); Spinal Column Injury; Vertebral Fracture

  MAUDE report 14740034 ↗
• InjuryJun 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A L2 COMPRESSION FRACTURE 40 DAYS POST-OP. PATIENT WAS SUBSEQUENTLY TREATED WITH A L2 VERTEBROPLASTY/ABALOPARATIDE. INTRACEPT TREATMENT OCCURRED ON L2-S1, 5 LEVELS.

  Patient problems: Bone Fracture(s); Spinal Column Injury; Vertebral Fracture

  MAUDE report 14740032 ↗
• InjuryJun 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A L4 SUPERIOR ENDPLATE FRACTURE POST-OP. INTRACEPT TREATMENT OCCURRED ON L4-S1 LEVELS. PLANNED FOR VERTEBRAL AUGMENTATION PROCEDURE FOR TREATMENT.

  Patient problems: Bone Fracture(s); Spinal Column Injury; Vertebral Fracture

  MAUDE report 14740031 ↗