CAPSTONE CONTROL™ Spinal System 4011022Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169109056), received between Jan 13, 2017 and Jan 19, 2025 — classified as 1 injury, 2 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 19, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR SPINAL STENOSIS. IT WAS REPORTED THAT, THE CAGE WAS BROKEN. THE PROCEDURE OR TECHNIQUE PERFORMED WAS TRANSFORAMINAL LUMBAR INTERBODY FUSION. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AND NO ADDITIONAL TREATMENT OR SURGERY PERFORMED. THERE WERE NO BROKEN FRAGMENTS OF IMPLANT REMAINS IN PATIENT BODY. THERE WAS NO DELAY IN PROCEDURE REPORTED AS A RESULT AND THE REPORTED PRODUCT WAS LOST AFTER SENDING IT FOR WASH. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21187830 ↗
• MalfunctionFeb 15, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH FAILURE OF BONE FUSION OCCURRED DUE TO LOOSENING OF THE POSTERIOR SCREW AND UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION (OLIF) AT L3,L4,L5. DURING SURGERY, WHEN REMOVING THE CAGE BY PERFORMING OLIF, THE MARKER OF CAGE WAS BROKEN. FRAGMENTS OF THE BROKEN PART REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7272521 ↗
• InjuryJan 13, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT PATIENT WITH DEGENERATIVE SCOLIOSIS UNDERWENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION SURGERY AT L2/3/4/5 ON (B)(6) 2016 AND POSTERIOR LUMBAR INTERBODY FUSION AT L5/6 AND L6/S AS TWO-STAGE SURGERY ON (B)(6) 2016. ON AN UNKNOWN DATE, POST-OP, THE CAGE INSERTED AT L6/S IN PLIF SURGERY BACKED OUT. LOWER LIMB SYMPTOM WAS OBSERVED AS CAGE BACKED OUT AT L6/S. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2016 IN WHICH SPACER WAS EXPLANTED AND DISCARDED AND NERVE SYMPTOM WAS RESOLVED.

  Patient problems: No Code Available

  MAUDE report 6248753 ↗