CAPSTONE CONTROL™ Spinal System 4001027Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169109711), received between Jun 8, 2018 and Jun 8, 2018 — classified as 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH DEGENERATIVE DISC DISEASE AND UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4-5. DURING SURGERY, THE SPACER BROKE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS OF THE BROKEN PART REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7581324 ↗
• MalfunctionJun 8, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH DEGENERATIVE DISC DISEASE AND UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4-5. DURING SURGERY, THE SPACER BROKE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS OF THE BROKEN PART REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7581317 ↗