CAPSTONE® Spinal System 2990932Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994387165), received between Dec 12, 2024 and Dec 12, 2024 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM CLINICAL STUDY, HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH CLINICAL STUDY ID (B)(6). IT WAS REPORTED THAT, PATIENT HAD ABNORMAL SENSORY FUNCTION (L5 RIGHT LIGHT TOUCH AND PIN PRICK). PREVIOUS SENSORY FUNCTION WAS NOTED AS NORMAL AND WAS NOW NOTED AS ABNORMAL FOR L5 RIGHT LIGHT TOUCH AND PIN PRICK. PROCEDURE/TECHNIQUE PERFORMED WAS TRANSFORAMINAL LUMBAR INTERBODY FUSION OPEN SURGICAL ACCESS. LEVELS IMPLANTED WERE L4-L5 AND L5-S1. SITE RELATED ASSESSMENT: ADVERSE EVENT WAS NOT RELATED TO CAPSTONE PEEK SPINAL SYSTEM IMPLANT, POSTERIOR SUPPLEMENTAL FIXATION SYSTEM, TRANSFORAMINAL LUMBAR INTERBODY FUSION GRAFTING MATERIAL AND TO PROCEDURE. SPONSOR ASSESSMENT (OC MUO): CEC ADJUDICATED AS POSSIBLE RELATED TO TLIF PROCEDURE, TLIF GRAFTING MATERIAL, BODY FUSION DEVICE, AND SUPPLEMENTAL FIXATION SYSTEM. SITE SERIOUSNESS ASSESSMENT: SEVERITY OF ADVERSE EVENT WAS MILD. OUTCOME OF ADVERSE EVENT WAS RECOVERING/RESOLVING. THE ONSET DATE WAS (B)(6) 2024. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Paresthesia; Unspecified Nervous System Problem

  MAUDE report 20911628 ↗