Intracept FG 0038Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00852454006127), received between Nov 15, 2018 and Nov 15, 2018 — classified as 1 injury.

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) MALE PATIENT WITH LONG HISTORY OF LOW BACK PAIN UNDERWENT UNCOMPLICATED L3 AND L4 INTRACEPT PROCEDURE ON (B)(6) 2018 FOR PRESUMED VERTEBROGENIC PAIN. THE PATIENT HAD NO HISTORY OF OSTEOPOROSIS AND THERE WAS NO CLINICAL SUSPICION OF BONE FRAGILITY. PER THE TREATING PHYSICIAN, THE PATIENT FAILED TO IMPROVE POST-PROCEDURE AND HAD SLIGHT WORSENING OF HIS USUAL BASELINE PAIN. PATIENT CONTINUED TO BE ABLE TO PERFORM ADLS, INCLUDING WORKING FULL TIME WITHOUT ANY MEDICATIONS. THE LACK OF IMPROVEMENT LED THE PHYSICIAN TO PERFORM MRI OF THE LUMBOSACRAL SPINE ON (B)(6) 2018, SHOWING NEW L4 SUPERIOR ENDPLATE FRACTURE. THERE WAS NO LOSS OF VERTEBRAL BODY HEIGHT AND NO EVIDENCE OF NEURAL IMPINGEMENT OR SPINAL CANAL COMPROMISE. THE RF ABLATION ZONE DID NOT APPEAR TO OVERLAP WITH THE ENDPLATE. THE PATIENT UNDERWENT UNCOMPLICATED VERTEBRAL KYPHOPLASTY ON (B)(6) 2018 WITH RESOLUTION OF PAIN.

  Patient problems: Bone Fracture(s)

  MAUDE report 8074276 ↗