CAPSTONE® Spinal System 2990826Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994291035), received between Jul 27, 2020 and Nov 19, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT IMPLANTED WITH SPACER HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) THERAPY FOR L3-L4 HERNIATED INTERVERTEBRAL DISC AND GRADE 2 SPONDYLOLISTHESIS. IT WAS REPORTED THAT AFTER TRIALING, THE SURGEON FULLY INSERTED THE CAGE. WHEN ATTEMPTING TO IMPACT THE CAGE FURTHER INTO POSITION, THE SURGEON NOTED THAT THE CAGE HOLDER HAD DETACHED FROM THE CAGE. THE SURGEON REMOVED THE IMPLANT AND ASSOCIATED FRAGMENTS COMPLETELY. A NEW CAGE WAS THEN OPENED, IMPLANTED, AND THE PROCEDURE WAS COMPLETED UNEVENTFULLY, NO PATIENT SYMPTOM WERE REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23592113 ↗
• MalfunctionSep 14, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A CAGE FOR A LUMBAR FUSION. IT WAS REPORTED THAT THE POSTERIOR THIRD OF THE LUMBAR FUSION CAGE WAS BROKEN. THE IMPLANT BROKE AND THERE WAS NO FRAGMENT OF THE INSTRUMENT REMAINING IN THE PATIENT'S BODY. THE FUSION CAGE WAS BROKEN DURING THE SURGERY OF THE CUSTOMER DURING IMPLANTATION. THE PATIENT IS ASSOCIATED WITH THE EVENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. THE PRE- OP DIAGNOSIS WAS A LUMBAR DISC HERNIATION. DETAILS OF LEVELS IMPLANTED: IN THE FIRST IMPLANTATION, THE SURGEON HIT THE HOLDER WITH A BONE HAMMER. DURING THE PROCESS OF IMPLANTING THE FUSION CAGE, THE FUSION CAGE HAD NOT BEEN COMPLETELY IMPLANTED IN THE INTERVERTEBRAL SPACE. THERE WAS NO ADDITIONAL SURGERY OR TREATMENT PERFORMED. THE PRODUCT WAS EXPLANTED AND REPLACED WITH A MEDTRONIC PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10527258 ↗
• MalfunctionJul 27, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A CAGE FOR A LUMBAR DISCECTOMY. IT WAS REPORTED THAT WHEN THE SURGEON COMPLETED THE LUMBAR DISCECTOMY AND THEN PREPARED TO IMPLANT THE CAGE, HE PUT THE CAGE ON THE CAGE HOLDER AND PUNCHED INTO THE L4-5, THE CAGE WAS BROKEN AT THE CAGE HOLDER AND CAGE CONNECT PLACE. THE IMPLANT BROKE AND THERE WERE NO FRAGMENTS OF THE IMPLANT REMAINING IN THE PATIENT BODY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. THE PRE-OP DIAGNOSIS WAS LUMBAR DDD. LEVELS IMPLANTED WERE L4-L5. DATE OF IMPLANT AND EXPLANT WAS (B)(6) 2020. THE DEVICE WAS EXPLANTED. THE PRODUCT WAS REPLACED BY A MEDTRONIC PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10324762 ↗