CAPSTONE® Spinal System 2991222Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994290960), received between Oct 5, 2017 and Oct 21, 2024 — classified as 4 injuries.

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

• InjuryOct 21, 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) REGARDING AN EVENT WHICH OCCURRED POST A CLINICAL STUDY (STUDY ID: (B)(4)) SPINAL FUSION PROCEDURE IN A PATIENT (PATIENT ID: (B)(6)). IT WAS REPORTED THAT PATIENT REPORTS LOW BACK PAIN AND RATES IT A 6-7 OUT OF 10. MILD PAIN WITH RANGE OF MOTION. PI STATES PROBABILITY OF MILD DISC STRAIN AND COMPLETED A STEROID INJECTION. REFILLED DICLOFENAC AND FLEXERIL FOR PAIN CONTROL. PRESCRIBED PHYSICAL THERAPY AND IF NO IMPROVEMENTS IN 6-8 WEEKS, THEN WILL SEND FOR AN MRI. PATIENT ALSO HAD ACUTE CYSTITIS, HYPOXIC-ISCHEMIC ENCEPHALOPATHY, LUMBAR RADICULOPATHY, SEVERE OBSTRUCTIVE SLEEP APNEA. NO PRODUCT MALFUNCTION REPORTED. SPONSOR ASSESSMENT: NOT RELATED TO PROCEDURE, POSSIBLE TO TLIF GRAFTING MATERIAL (AUTOGRAFT), BODY FUSION DEVICE (CAPSTONE), AND POSTERIOR SUPPLEMENTAL FIXATION SYSTEM. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.ENT.

  Patient problems: Apnea; Encephalopathy; Neuropathy; Pain

  MAUDE report 20492254 ↗
• InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A REGULATORY BODY VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN UNKNOWN INDICATION FOR SPINAL THERAPY. IT WAS REPORTED THAT POSTERIOR LUMBAR DECOMPRESSION, BONE GRAFTING, FUSION AND INTERNAL FIXATION WERE PERFORMED ON (B)(6) 2023. LUMBAR 4, LUMBAR 5, AND SACRAL 1 PEDICLES WERE IMPLANTED, WITH A TOTAL OF 6 CROSSLINKS. A FUSION CAGE WAS IMPLANTED BETWEEN THE FOURTH AND FIFTH LUMBAR VERTEBRAE. WOUND INFECTION WAS FOUND ON (B)(6) 2023, AND A POSTERIOR LUMBAR DEBRIDEMENT, SUTURE, PERFUSION, IRRIGATION AND DRAINAGE WAS PERFORMED. THE PATIENT HAD A HYPERSENSITIVE CONSTITUTION, WAS ALLERGIC TO CEPHALOSPORIN ANTIBIOTICS, AND THE ANTIBIOTICS USED TO PREVENT INFECTION WERE NOT STRONG ENOUGH.

  Patient problems: Post Operative Wound Infection

  MAUDE report 18656825 ↗
• InjuryMar 16, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  INITIAL PROCEDURE: POSTERIOR LUMBAR INTERBODY FUSION PRE-OP DIAGNOSIS: CAGE BETWEEN THE L2/3 BACKED-OUT AND L2 SCREW LOOSENED IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE CAGE BETWEEN L2/3 BACKED OUT AND THE S4 SCREW ON L2 LOOSENED. NO BREAKAGE OF PRODUCTS WAS REPORTED. AN ADDITIONAL SURGERY WAS PLANNED TO BE PERFORMED ON (B)(6). NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7344223 ↗
• InjuryOct 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT POSTERIOR LUMBAR FUSION DUE TO DISC HERNIATION. POST-OP, INTER-VERTEBRAL SPACE INFECTION WAS OBSERVED ACCOMPANIED BY FEVER DISCOMFORT. PATIENT WAS HOSPITALIZED. PRODUCTS REMAIN IN THE PATIENT'S BODY. POST-OPERATIVE DEBRIDEMENT SURGERY WAS PERFORMED.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 6916562 ↗