CAPSTONE® Spinal System 2990822Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00613994291042), received between Nov 20, 2018 and Jan 21, 2025 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL(HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED IN POSTERIOR LUMBAR INTERBODY FUSION SURGERY (PLIF). IT WAS REPORTED THAT THERE WERE TWO TARGET SEGMENTS, AND WHEN THE SECOND CAPSTONE WAS APPLIED, THE FLUOROSCOPY FOUND THAT THE DEPTH OF THE CAPSTONE WAS NOT IDEAL. THE CAPSTONE WAS ATTEMPTED TO BE TAKEN OUT, AND DURING THE REMOVAL WITH A SLIDE HAMMER, THE POSTERIOR EDGE OF THE CAPSTONE WAS BROKEN. LATER, REPLACED WITH A NEW CAPSTONE TO USE AND THE SURGERY WAS COMPLETED. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE WAS LUMBAR SPINAL STENOSIS. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT BODY. THERE WAS A DELAY OF ABOUT 15 MINUTES IN THE OVERALL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21196977 ↗
• MalfunctionApr 18, 2024Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS WAS CERVICAL SPONDYLOSIS. IT WAS REPORTED THAT, THE CAGE WAS BROKEN. PROCEDURE OR TECHNIQUE PERFORMED WAS ANTERIOR CERVICAL DISCECTOMY AND FUSION. THERE WERE NO FRAGMENTS OF BROKEN CAGE LEFT INSIDE PATIENT BODY. NO PATIENT SYMPTOMS REPORTED, NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19132153 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L4/5 PLIF. IT WAS REPORTED THAT THE PATIENT PRESENTED SPINAL INFECTION WITH THE IMPLANTS THAT WERE IMPLANTED ON (B)(6) 2013 AND ADDITIONAL SURGERY WAS PERFORMED ON (B)(6) 2022 TO REMOVE THE IMPLANTS. THE IMPLANTS WERE REMOVED USING AN INTERMUSCULAR APPROACH, AVOIDING THE PARASPINAL MUSCLES AND CLEANSING WAS PERFORMED AFTER IMPLANT REMOVAL. THE INFECTION WAS DERIVED FROM THE SITE WHERE THE IMPLANT WAS FIXATED, AND ALSO OBSERVED IN L1/2, SO CLEANED UNDER AN ENDOSCOPE. THERE WAS NO DEVICE MALFUNCTION REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 15161792 ↗
• MalfunctionNov 2, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN INDICATION OF LUMBAR DISC HERNIATION IN NEED OF LUMBAR TLIF PROCEDURE USED IN SPINAL THERAPY. IT WAS REPORTED THAT WHEN KNOCKED THE PRODUCT INTO THE INTERVERTEBRAL SPACE HALF, IN THE MIDDLE, THE PRODUCT BROKE. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WAS A DELAY OF LESS THAN 60 MINS IN OVERALL PROCEDURE TIME. 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; No Known Impact Or Consequence To Patient

  MAUDE report 10768873 ↗
• MalfunctionJul 17, 2020Migration; Migration

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¿S COMMENTS:

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10287537 ↗
• InjuryJun 30, 2020Migration; Migration

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

  Patient problems: Failure of Implant; Pain

  MAUDE report 10211084 ↗
• InjuryNov 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION AT L5/S.POST OPERATIVELY , AFTER THE FIXATION AT TH11-L5, SPONDYLOLISTHESIS OCCURRED AT L5/S AND THERE WAS LOWER EXTREMITY SYMPTOM.. THE PATIENT SUFFERED FROM DISABILITY.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9390987 ↗
• MalfunctionNov 20, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH SPINAL DEGENERATION AND UNDERWENT SURGERY. DURING SURGERY, THE SPACER BROKE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF THE SPACER REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8093405 ↗