CAPSTONE® Spinal System 2991022Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00613994291004), received between May 12, 2017 and Sep 22, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Migration

  Information was received from multiple sources (Manufacturer Representative, Healthcare Provider, Clinical Study) regarding a patient with clinical(b)(6), study (b)(4) and subevent number 8. It was reported that there was subsidence of interbody spacers on L2-L3 and L3-L4. There was no treatment planned but the patient was encouraged to limit activities since she had been very active.  Diagnostic action taken includes CT without Contrast on(b)(6) 2024. There were no patient symptoms reported. There were no further complications reported regarding the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50850494 ↗
• MalfunctionSep 22, 2026Migration

  Information was received from multiple sources (Manufacturer Representative, Healthcare Provider, Clinical Study) regarding a patient with clinical ID (b)(6), study ID MDT17074S D1706 and subevent number 8. It was reported that there was subsidence of interbody spacers on L2-L3 and L3-L4. There was no treatment planned but the patient was encouraged to limit activities since she had been very active.  Diagnostic action taken includes CT without Contrast on 2024-Jun-11. There were no patient symptoms reported. There were no further complications reported regarding the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50850484 ↗
• MalfunctionFeb 19, 2026Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT WITH CLINICAL ID (B)(6), STUDY ID (B)(6). IT WAS REPORTED THAT LOOSENING OF INTERNAL FIXATION AND FUSION DEVICES MAY OCCUR. THE CT SCAN OF THE LUMBAR SPINE SHOWED: BONE DESTRUCTION, ABSORPTION AND WIDENING OF THE RADIOLUCENT AREA AROUND THE INTERNAL FIXATION AND INTERVERTEBRAL FUSION DEVICE, AND INCREASED. ONSET DATE 2025-06-19. PRIMARY DIAGNOSIS WAS STENOSIS. AE REPORTED FOR LOW BACK PAIN AND CURRENTLY NOT RECOVERED / NOT RESOLVED. SITE AND SPONSOR ASSESSMENTS: PROBABLE RELATED TO BOTH THE IB FUSION DEVICE (CAPSTONE PEEK) AND POSTERIOR SUPPLEMENTAL FIXATION SYSTEM, AND NOT RELATED TO THE PROCEDURE OR THE TLIF GRAFTING MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24386736 ↗
• MalfunctionFeb 18, 2026Device Dislodged or Dislocated

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH CLINICAL ID (B)(6), STUDY ID (B)(6) AND INCIDENT TYPE AE SUBEVENT NUMBER: 3. PRIMARY DIAGNOSIS: STENOSIS DESCRIPTION: LOW BACK PAIN ONSET DATE: 2024-10-14 OUTCOME STATUS: NOT RECOVERED/ NOT RESOLVED INTERVENTIONS: ACTION SUBTYPE: AE RESULT IN HOSPITALIZATION ACTION RESULT: NO ACTION SUBTYPE: ANY OTHER ACTION(S) TAKEN ACTION RESULT: NO ACTION SUBTYPE: DID THE AE RESULT IN ANY TREATMENT ACTION RESULT: YES ACTION SUBTYPE: DRUG THERAPY ACTION RESULT: YES ACTION SUBTYPE: PHYSICAL THERAPY ACTION RESULT: YES SITE SERIOUSNESS ASSESSMENT: THERE IS NO CONGENITAL ANOMALY, DEATH, DISABILITY, HOSPITALIZATION, LIFE THREATENING, MEDICAL INTERVENTION AND SEVERITY OF ADVERSE EVENT IS MILD. SITE RELATED ASSESSMENT: IT IS PROBABLE RELATED TO POSTERIOR SUPPLEMENTAL FIXATION SYSTEM AND NOT RELATED TO CAPSTONE PEEK SPINAL SY STEM, TLIF GRAFTING, STUDY PROCEDURE. ADVERSE EVENT INFO: DOES THE ADVERSE EVENT INVOLVE A LUMBOSACRAL SPINAL LEVEL: NO DIAGNOSTICS: ACTION TYPE: DIAGNOSTIC ACTION SUBTYPE: CT WITHOUT CONTRAST1 ACTION RESULT: INTERNAL FIXATION AND THE FUSION DEVICE MAY BECOME LOOSE ACTION DATE: 202

  Patient problems: Pain

  MAUDE report 24374487 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, CLINICAL STUDY) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LUMBOSACRAL SPINAL LEVEL THERAPY AT LEVELS L3-L4 AND L4-L5 FOR PRIMARY DIAGNOSIS OF INSTABILITY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERSISTENT BACK PAIN ABOVE THE FUSION SITE ON THE RIGHT SIDE FOLLOWING A BUS ACCIDENT ON (B)(6) 2022, DESCRIBED AS STABBING, SHARP, AND ACHING ABOVE THE RIGHT BUTTOCK. DIAGNOSTIC TESTS, INCLUDING AN MRI WITHOUT CONTRAST ON (B)(6) 2023, REVEALED NO PATHOLOGICAL CHANGES. INJECTIONS ON (B)(6) 2023 PROVIDED TEMPORARY RELIEF (100% FOR 4-10 HOURS), BUT BURNING PAIN PERSISTED BY (B)(6) 2023. RADIOFREQUENCY ABLATION ON (B)(6) 2023 RESULTED IN 95-100% RELIEF BY (B)(6) 2023. TREATMENTS INCLUDED RIGHT-SIDED L3 AND L5 MEDIAL BRANCH INJECTIONS ((B)(6) 2023), RADIOFREQUENCY ABLATION ((B)(6) 2023), AND RIGHT L3 AND L5 RF ABLATION WITH TRIAMCINOLONE INJECTION ON (B)(6) 2023 AND (B)(6) 2024. HOWEVER, BY (B)(6) 2024, THE PATIENT EXPERIENCED RIGHT- AND LEFT-SIDED BACK PAIN WHEN COUGHING, PARTIALLY ALLEVIATED BY LIDOCAINE PATCHES AND A TENS UNIT. IN (B)(6) 2024, THE PATIENT UNDERWENT INTRAMUSCULAR KETAMINE THERAPY. EPI

  Patient problems: Pain

  MAUDE report 23000982 ↗
• MalfunctionAug 31, 2023Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT HAVING SPINAL THERAPY FOR DEGENERATIVE LUMBAR DISEASE. IT WAS REPORTED THAT THE SPACER WAS BROKEN DURING IMPLANTATION IN OPEN LUMBAR SURGERY, AND IT WAS REMOVED DURING THE OPERATION AND REPLACED WITH A NEW ONE. NO FRAGMENT OF THE IMPLANT OR INSTRUMENT IS REMAINING IN THE PATIENT. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE TAIL OF THE FUSION CAGE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17659252 ↗
• MalfunctionMay 16, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING THORACOLUMBAR S PINE DEGENERATION SURGERY. IT WAS REPORTED THAT THE CAPSTONE HAS BROKEN. THE DEVICE FRAGMENTS WERE LEFT INSIDE THE PATIENT. THE PATIENT HAD A HALF CFUSION INSIDE THE BODY. NO PLANS TO WITHDRAW AT THE MOMENT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 14405777 ↗
• MalfunctionAug 16, 2019Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION AT L3/4/5 DUE TO "LSCS". INTRA-OPERATIVELY, DURING PLIF BETWEEN L3/4, THE RIGHT CAGE INTERFERED WITH THE LEFT CAGE, THE LEFT CAGE FELL TO THE SIDE AND WAS PLACED LYING DOWN ABOUT 90% COMPARED TO NORMAL PLACEMENT (LOOKED LIKE A LIF.) WHEN CONFIRMING THE X-RAY, THE FORWARD PROTRUSION SEEMED TO BE ABOUT 1/4 TO 1/5 OF THE CAGE. PLACEMENT OF ANOTHER CAGE WAS GIVEN UP AND SPONGE BONE WAS FILLED ON THE POSTERIOR SIDE OF THE CAGE, AND THE PROCEDURE RETURNED TO NORMAL. THERE WAS A DELAY OF LESS THAN 60 MINS IN PROCEDURE TIME AS A RESULT OF ALLEGED EVENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF ALLEGED EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8901971 ↗
• InjuryMay 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEVEL: L3-L5 PROCEDURE: OPEN TRANSFORAMINAL INTERBODY FUSION IT WAS REPORTED THAT POST-OP, DURAL TEAR OCCURRED. SMALL PUNCTATE DURAL RENT OCCURRED JUST BELOW TAKE OFF OF L5 NERVE ROOT. DURAL TEAR WAS REPAIRED DURING INDEX SURGERY, SURGERY WAS ¿REPAIRED WITH 6-0 PROLENE SUTURE AND CLOSED WITH DURAGEN¿. PATIENT OUTCOME: RESOLVED.

  Patient problems: Injury

  MAUDE report 7478378 ↗
• MalfunctionMay 12, 2017Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT UNDERWENT MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (MIS TLIF) AT LEVELS L4-S1. INTRA-OP, PART OF CAGE WAS BROKEN WHEN THE SURGEON MALETED IT. PRODUCT CAME IN CONTACT WITH THE PATIENT. NO BROKEN FRAGMENTS REMAIN IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6562564 ↗