CAPSTONE® Spinal System 2991326Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994387394), received between Dec 28, 2023 and Jun 20, 2024 — classified as 2 injuries.

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.

• InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY (B)(6 ) REGARDING A PATIENT WITH CLINICAL ID (B)(4). IT WAS REPORTED THAT THERE WAS NON-UNION AT L5-S1. SPONSOR ASSESSMENT POSSIBLE RELATED TO THE TLIF GRAFTING MATERIAL, TO THE CAPSTONE PEEK AND TO THE POSTERIOR SUPPLEMENTAL FIXATION SYSTEM SITE RELATED ASSESSMENT  RELATED TO THE TLIF GRAFTING MATERIAL, AND PROBABLY RELATED TO STUDY PROCEDURE.  SEVERITY OF AE - MODERATE THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. CT ON (B)(6) 2023: NON-UNION AT L5/ S1, BROKEN S1 PEDICLE SCREW DESCRIPTION NON UNION AT L5/S1 AND L4/L5 ACTION TYPE: DIAGNOSTIC ACTION SUBTYPE: CT WITHOUT CONTRAST2 ACTION RESULT: NON-UNION L5?S1 AND L4/L5 ACTION DATE: ON (B)(6) 2023 ACTION TYPE: DIAGNOSTIC ACTION SUBTYPE: WERE ANY DIAGNOSTIC TEST PERFORMED ACTION RESULT: Y NARRATIVE: NO DEFINITE BONY BRIDGING ACROSS THE VERTEBRAL BODIES AT L4/L5. UPDATE RECEIVED BROKEN RIGHT S1 PEDICLE SCREW SURGERY :VOLUME OF ALLOGRAFT BONE IMPLANTED (IF NEEDED TO SUPPLEMENT LOCAL BONE AUTOGRAFT) - SUPERIOR TREATED LEVEL: 0 CC OUTCOME STATUS: RECOVERING/RESOLVING NARRATIVE- 36M: PT REPORTS WORSENING LOW

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 19573596 ↗
• InjuryDec 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT WITH CLINICAL ID: (B)(6) AND STUDY ID: (B)(4). IT WAS REPORTED THAT, PATIENT HAD L5 SUPERIOR PLATE MILD COMPRESSION FRACTURE NOTED ON (B)(6) 2022 ON COMPUTED TOMOGRAPHY SCAN. THERE WAS NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT.  ONSET DATE: ON (B)(6) 2022, DESCRIPTION: COMPRESSION FRACTURE L5 SUPERIOR PLATE. OUTCOME DATE: ON (B)(6) 2022, ADVERSE EVENT INFO: DOES THE ADVERSE EVENT INVOLVE A LUMBOSACRAL SPINAL LEVEL: YES IF YES, LEVELS INVOLVED: L4-L5 SITE SERIOUSNESS ASSESSMENT:  SEVERITY OF AE: MILD SITE RELATED ASSESSMENT: POSSIBLY RELATED TO CAPSTONE PEEK SPINAL SYSTEM IMPLANT, AND NOT RELATED TO POSTERIOR SUPPLEMENTAL FIXATION SYSTEM, TLIF GRAFTING MATERIAL AND PROCEDURE.  ADDITIONAL INFORMATION RECEIVED: SPONSOR ASSESSMENT: POSSIBLE RELATED TO THE INTERBODY DEVICE. ADDITIONAL INFORMATION RECEIVED: ON 07/OCT/2021 TRANSFORAMINAL LUMBAR INTERBODY FUSION WAS PERFORMED BY OPEN SURGICAL ACCESS. THE TREATED LEVELS RE L4-L5.

  Patient problems: Bone Fracture(s)

  MAUDE report 18407708 ↗