CAPSTONE® Spinal System 2991226Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00613994290953), received between Nov 21, 2016 and Mar 7, 2025 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2025Migration; Migration

  IT WAS REPORTED THAT PATIENT AWOKE FROM SURGERY WITH PAIN IN HER LOWER BACK/SURGICAL SITE. SHE DESCRIBES THE PAIN AS FEELING OF TIGHTNESS IN THE LOWER BACK AREA. THIS AN EXPECTED OCCURRENCE POST-SURGERY. USING THE 0-10 PAIN SCALE, THE PAIN WAS RATED AS AN 8. LEVELS INVOLVED: L4-L5, SURGERY DATE: ON (B)(6) 2020, SURGICAL ACCESS: MINIMALLY INVASIVE (I.E. METRX OR QUADRANT). SIDE OF CAPSTONE INSERTION - SUPERIOR TREATED LEVEL: RIGHT. SOAK TIME FOR THE RHBMP-2 ONTO THE ACS PRIOR TO IMPLANTATION - SUPERIOR TREATED LEVEL: 30 MINUTES VOLUME OF LOCAL BONE AUTOGRAFT IMPLANTED ¿ SUPERIOR TREATED LEVEL: 1 CC VOLUME OF ALLOGRAFT BONE IMPLANTED (IF NEEDED TO SUPPLEMENT LOCAL BONE AUTOGRAFT) - SUPERIOR TREATED LEVEL: 8 CC TOTAL ESTIMATED BLOOD LOSS: 20 ML. THE SUBJECTS INTERBODY SPACE PREPARATION AND GRAFT PLACEMENT COMPLETED AS INSTRUCTED PER THE SURGICAL CHECKLIST. SITE SERIOUSNESS ASSESSMENT: THIS EVENT WAS NOT RELATED TO ANY CONGENITAL ANOMALY, DEATH, DISABILITY, HOSPITALIZATION, LIFE THREATEN ING, MEDICAL INTERVENTION, AND SEVERITY OF AE IS MODERATE. SITE RELATEDNESS ASSESSMENT: THE EVENT IS NOT RELATED TO ANY OF THE DEVICES USED BUT CASUAL RELATIONSHIP WITH STUDY PROCEDURE-TRANSFORAMINAL L

  Patient problems: Pain

  MAUDE report 21544488 ↗
• InjuryApr 21, 2021Migration; Migration

  UPDATED INFORMATION RECEIVED ON 15-NOV-2021: ACTION SUBTYPE: CT WITHOUT CONTRAST5 ACTION RESULT: DORSAL MIGRATION OF THE INTERBODY SPACER ACTION DATE: 2021-11-09 ACTION TYPE: DIAGNOSTIC ACTION SUBTYPE: X-RAY4 ACTION RESULT: DORSAL MIGRATION OF THE INTERBODY SPACER ACTION DATE: 2021-11-09 UPDATED INFORMATION RECEIVED ON 29-NOV-2021: SPONSOR ASSESSMENT (OC MUO): RESULT: YES COMMENTS: CEC ASSESSED AS CAUSAL RELATIONSHIP TO PROCEDURE AND INTERBODY DEVICE, POSSIBLE RELATED TO TLIF GRAFTING, NOT RELATED TO POSTERIOR FIXATION. UPDATED INFORMATION RECEIVED ON 03-DEC-2021: SITE RELATED ASSESSMENT: SITE ASSESSED AS EVENT IS UNLIKELY TO BE RELATED TO TLIF GRAFTING MATERIAL.

  Patient problems: Pain

  MAUDE report 11698652 ↗
• MalfunctionMar 7, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OPEN TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) DUE TO RADICULOPATHY. INTRA-OP, THE CAGE BROKE INTO TWO PIECES DURING IMPLANTATION AND POSTERIOR AND 1/4TH OF THE IMPLANT WAS TAKEN OUT WITH THE INSERTER. THE REMOVAL OF THE IMPLANT WAS DONE IMMEDIATELY DURING THE PROCEDURE. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THERE IS NO FURTHER REMOVAL SURGERY PLANNED FOR REMOVING THE REMAINING DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8397991 ↗
• MalfunctionJul 18, 2018Crack

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY DUE TO SPINAL DEGENERATION. INTRA-OP, THERE WAS A CRACK IN THE CAGE. THE DEVICE CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7698643 ↗
• MalfunctionMay 15, 2018Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTER-BODY FUSION SURGERY (TLIF) DUE TO DISC HERNIATION. INTRA-OPERATIVELY, DURING THE IMPLANTATION, SPACER BROKE. THE DOCTOR REMOVED IT AND REPLACED WITH A NEW ONE AND THE OPERATION WAS COMPLETED SMOOTHLY. PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF THE IMPLANT REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7514164 ↗
• InjuryApr 13, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  TYPE OF PROCEDURE OR TECHNIQUE USED : TRANSFORAMINAL LUMBAR INTERBODY FUSION LEVELS: L1-S IT WAS REPORTED THAT POST-OP, THE CAGE BACKED OUT. RE-OPERATION WAS PERFORMED AND THE CAGE WAS REMOVED. FROM AROUND (B)(6) 2018, THE PATIENT HAD PAIN AND WAS UNABLE TO WALK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7430663 ↗
• InjuryNov 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRE-OP DIAGNOSIS: L4/L5 DISC BULGING, LIGAMENTUM FLAVUM THICKENING AND SPINAL STENOSIS. 2 TYPES OF DIABETES MELLITUS. HYPERTENSION. RIGHT TIBIA FRACTURE AFTER OPERATION. OTITIS MEDIA. SINUS BRADYCARDIA. PROCEDURE USED: SPINAL INTERNAL FIXATION SYSTEM FOR OPEN LUMBAR FUSION SURGERY IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR LUMBAR INTERBODY FUSION. POST-OP, ON (B)(6) 2017 THE WOUND WAS OOZING EXUDATE SHOWING SUSPICION OF INFECTION. ON (B)(6) 2017, WOUND DEBRIDEMENT WAS PERFORMED.

  Patient problems: Unspecified Infection

  MAUDE report 7062548 ↗
• InjuryAug 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR DISCECTOMY AND FUSION DUE TO LUMBAR DISC HERNIATION. POST OP, ON AN UNKNOWN DATE THE PATIENT WAS DIAGNOSED WITH INFECTION. DUE TO INFECTION THE PATIENT UNDERWENT A REVISION SURGERY IN WHICH THE IMPLANT WAS COMPLETELY EXPLANTED. THIS EXPLANTATION HAPPENED BEFORE FUSION. NO PATIENT COMPLICATION WAS REPORTED POST REVISION SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 6783833 ↗
• InjuryNov 21, 2016Migration or Expulsion of Device; Migration or Expulsion of Device

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: LUMBAR SPINAL CANAL STENOSIS IT WAS REPORTED THAT PATIENT UNDERWENT L5/S POSTERIOR LUMBAR INTERBODY FUSION. ON AN UNKNOWN DATE, POST-OP, THE CAGE WAS BACKED OUT AND REVISION SURGERY WAS PERFORMED DUE TO RECURRENCE OF SYMPTOMS DUE TO CAGE BACK OUT. IMPLANTS WERE REPLACED.

  Patient problems: No Code Available; Stenosis

  MAUDE report 6116073 ↗