CAPSTONE® Spinal System 2991126Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994387387), received between Sep 10, 2020 and Jun 19, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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.

• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT WITH CLINICAL ID (B)(4) AND STUDY ID (B)(4) . IT WAS REPORTED THAT THE PATIENT COMPLETED A CT SCAN ON (B)(6) 2022. THE SURGEON REVIEWED THE SAME ON (B)(6) 2022 AND NOTICED LEFT-SIDED ECTOPIC BONE GROWTH WHICH COULD POTENTIALLY BE IMPACTING THE PATIENT'S LEFT LEG PAIN. THE PATIENT'S IMPLANTS ARE INTACT AND SHE APPEARS TO BE SOLIDLY FUSED IN THE INTERBODY SPACE. THE PATIENT DISCUSSED POTENTIALLY TRYING A TRANSFORAMINAL STEROID INJECTION AT THE L5-S1 SEGMENT WITH THE SURGEON. DIAGNOSTICS: MRI WITHOUT CONTRAST ON (B)(6) 2022 ; RESULTS- SOLIDLY FUSED IN THE INTERBODY SPACE; LEFT- SIDED ECTOPIC BONE GROWTH. SPONSOR ASSESSMENT: SPONSOR ASSESSED NOT RELATED TO STUDY PROCEDURE ; POSSIBLY RELATED TO TLIF GRAFTING MATERIAL ; UNLIKELY RELATED TO CAPSTONE PEEK SPINAL SYSTEM AND POSTERIOR SUPPLEMENTAL FIXATION SYSTEM. PRIMARY DIAGNOSIS: STENOSIS UPDATE RECEIVED: DESCRIPTION- LEFT-SIDED ECTOPIC BONE GROWTH AT L5-S1 OUTCOME STATUS- UNKNOWN NARRATIVE- AE INVOLVES LEVEL L5-S1 SEVERITY OF AE- MODERATE SITE RELATED ASSESSMENT- UNLIKELY RELATED TO CAPSTONE PEEK AND TLIF GRAFTING MATERIAL, NO

  Patient problems: Extraskeletal ossification

  MAUDE report 19565158 ↗
• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT ADVERSE EVENT INFO: DOES THE ADVERSE EVENT INVOLVE A LUMBOSACRAL SPINAL LEVEL: YES, IF YES, LEVELS INVOLVED: L5-S1 ADD SURGICAL PROCEDURE DATE - 01: (B)(6) 2023. DETAILS SURGICAL PROCEDURE - 01: FLUID ASPIRATION AT L5/S1 IS THE ADDITIONAL SURGICAL PROCEDURE AN ELECTIVE REMOVAL - 01: NO DOES THE ADDITIONAL SURGICAL PROCEDURE INVOLVE A SPINAL LEVEL - 01: YES ADD. SURGERY: IF YES, LEVELS INVOLVED - 01: L5-S1 DOES THE ADDITIONAL SURGICAL PROCEDURE INVOLVE AN EXPLANT RELATED TO THE STUDY PROCEDURE - 01: NO SITE RELATED ASSESSMENT: IT IS NOT RELATED TO CAPSTONE PEEK SPINAL SYSTEM, POSTERIOR SUPPLEMENTAL FIXATION SYSTEM, TLIF GRAFTING AND CAUSAL RELATED TO TRANSFORAMINAL INTERBODY LUMBAR FUSION (TLIF) PROCEDURE AT L5/S1. ADDITIONAL INFORMATION WAS RECEIVED THAT INTERVENTIONS : ACTION SUBTYPE: AE RESULT IN HOSPITALIZATION ACTION RESULT: NO ACTION SUBTYPE: ANY OTHER ACTION(S) TAKEN ACTION RESULT: YES OTHER ACTION TAKEN: MRI ORDERED ACTION SUBTYPE: DID THE AE RESULT IN ANY TREATMENT ACTION RESULT: YES ACTION SUBTYPE: DRUG THERAPY ACTION RESULT: YES ACTION SUBTYPE: INJECTION ACTION RESULT: YES INJECTION-1: INJECTION NAME: FACET STEROID INJECTION DATE:

  Patient problems: Pain; Seroma

  MAUDE report 18353688 ↗
• MalfunctionSep 10, 2020Break; Mechanics Altered; Break; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH LUMBAR DISC HERNIATION FOR POSTERIOR LUMBAR DECOMPRESSION AND FUSION. IT WAS REPORTED THAT THE SCREW THREAD OF THE HOLDING PART WAS BROKEN, AND THE WIRE SLIPPED. PRODUCT CAME IN CONTACT WITH PATIENT. DEVICE EXPLANTED AND WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10512647 ↗