CAPSTONE® Spinal System 2990926Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994387370), received between Nov 27, 2018 and Jan 26, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT USED IN L5-S1 POSTERIOR DECOMPRESSION AND INSTRUMENTED FUSION WITH TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SPINAL THERAPY FOR SPINAL STENOSIS. IT WAS REPORTED THAT WHEN SURGEON WANTED TO BRING BACK THE CAGE BY 2MM AND WAS TAPPING THE CAGE OUT WITH THE INSERTER HANDLE AND A MALLET. THE INSERTER SEEMED TO LET GO AND WHEN IT WAS PULLED OUT OF THE PATIENT, THE PIECE THAT THREADS ON WAS STILL ATTACHED TO THE CAGE AND THE END OF THE CAGE REMAINED. X-RAY WAS TAKEN AND THE CAGE APPEARED TO BE IN THE RIGHT SPACE, SO NO INTERVENTIONS WERE CARRIED TO RETRIEVE THAT PIECE OUT OF THE PATIENT THERE ARE NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE WERE NO ISSUES WITH THE INSERTER. IT WAS ENGAGED WITH THE CAGE PROPERLY AND NO CONCERNS WERE VOICED BY THE SURGEON. NO REVISION SURGERY TO BE PERFORMED AT THIS TIME AND THE REMAINING PART OF THE CAGE WAS DISCARDED BY STAFF.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21236959 ↗
• MalfunctionNov 25, 2020Crack; Crack

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN INDICATION OF LUMBAR DEGENERATION IN NEED OF POSTERIOR LUMBAR DECOMPRESSION AND FUSION USED IN SPINAL THERAPY. IT WAS REPORTED THAT DURING THE IMPLANTATION PROCESS, THE PROSTHESIS CRACKED, SO IT WAS REMOVED AFTER IMPLANTATION AND IMMEDIATELY REPLACED WITH A NEW PROSTHESIS. THERE WAS A DELAY OF LESS THAN 60 MINS IN OVERALL PROCEDURE TIME REPORTED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FRAGMENTS IN THE PATIENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10901947 ↗
• MalfunctionNov 27, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR INTERBODY FUSION AT L3/4/5 DUE TO DEGENERATIVE SCOLIOSIS. INTRA-OP, THE CAGE WAS INSERTED FROM THE LEFT OF L4/5, WHILE BEING HAMMERED, PHYSICIAN CONFIRMED FROM THE PERSPECTIVE IMAGE THAT THE MARKER LOOKED DIFFERENT FROM USUAL. WHEN THE PHYSICIAN ATTEMPTED TO ADJUST THE MARKER TO BE REFLECTED ON THE TRUE SAGITTAL, CAGE BROKE ALONG WITH A SNAP SOUND. A NEW CAGE OF ONE SIZE SMALLER WAS OPENED TO DEAL WITH ISSUE. NO FRAGMENT REMAINS IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8104996 ↗