CAPSTONE® Spinal System 2991026Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00613994290991), received between Nov 23, 2016 and Oct 30, 2024 — classified as 10 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 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 A PATIENT WITH CLINICAL ID: (B)(6) AND CLINICAL STUDY ID: (B)(6) HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) L3/L5 THERAPY. IT WAS REPORTED THAT PATIENT COMPLAINED OF RIGHT HAMSTRING AND BUTTOCK PAIN, RIGHT EXTENSOR HALLUCIS LONGUS WEAKNESS L4/5. CT SCAN ON (B)(6) 2022 CONFIRMED A RIGHT FORAMINAL STENOSIS L5/S1 AND ADJACENT LEVEL DEGENERATION (B)(6) 2023: TLIF L2/L3 AND L5/S1 WITH POSTERIOR INSTRUMENTATION AT L2/S1 WAS PERFORMED. PRIMARY DIAGNOSIS: STENOSIS INTERVENTIONS:   ACTION SUBTYPE: AE RESULT IN HOSPITALIZATION ACTION RESULT: N  ACTION SUBTYPE: ANY OTHER ACTION(S) TAKEN ACTION RESULT: Y OTHER ACTION TAKEN: MRI ORDERED ACTION SUBTYPE: DID THE AE RESULT IN ANY TREATMENT, ACTION RESULT: Y ACTION SUBTYPE: DRUG THERAPY, ACTION RESULT: YES ACTION SUBTYPE: SURGICAL TREATMENT, ACTION RESULT: YES OUTCOME STATUS: RECOVERED/ RESOLVED OUTCOME DATE: (B)(6) 2024 DIAGNOSTICS:  ACTION TYPE: DIAGNOSTIC ACTION SUBTYPE: CT WITHOUT CONTRAST1 ACTION RESULT: L5/S1 FORAMINAL STENOSIS ACTION DATE: (B)(6) 2022  ACTION TYPE: DIAGNOSTIC ACTION SUBTYPE: WERE ANY DIAGNOSTI

  Patient problems: Muscle Weakness/Atrophy; Pain

  MAUDE report 20566085 ↗
• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L3/L5 TLIF FOR AN INDICATION OF STENOSIS. IT WAS REPORTED THAT THE PATIENT DEVELOPED RADIATING PAIN SECONDARY TO SEVERE LEFT FORAMINAL STENOSIS AT L5/S1 AND DEGENERATIVE LEFTWARD TILT AT L5/S1. MRI ON 08/02/23: FACET ARTHROPATHY, LIGAMENTUM THICKENING, MODERATE CENTRAL CANAL STENOSIS, SEVERE RIGHT AND MODERATELY SEVERE LEFT FORAMINAL NARROWING AT L5/ S1. L2/L3 MODERATELY SEVERE CENTRAL STENOSIS, MODERATE BILATERAL FORAMINAL STENOSIS. THE PATIENT IS SCHEDULED FOR REMOVAL OF HARDWARE AT L3/L5 WITH TLIF AT L2/L3 AND L5/S1 AND POSTERIOR FUSION L2/S1. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL ACTION TAKEN: L5/S1 ESI ORDERED. THE AE RESULTED IN ADDITIONAL TREATMENT WITH PHYSIATRIST. OUTCOME STATUS: RECOVERING/RESOLVING. THE PATIENT UNDERWENT DIAGNOSTICS TEST OF MRI WITH CONTRAST 2 ON 2023-08-02. ACTION RESULT: L2/L3 AND L5/S1 CENTRAL AND FORAMINAL STE NOSIS. THE PATIENT UNDERWENT DIAGNOSTICS TEST OF X-RAY1 ON 2023-08-02. ACTION RESULT: UPPER LUMBAR MILD SPONDYLOSIS. SITE RELATED ASSESSMENT: THE EVENT IS PROBABLY RELATED TO CAPSTONE PEEK S

  Patient problems: Pain; Stenosis

  MAUDE report 18127922 ↗
• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L3/L5 TLIF FOR AN INDICATION OF STENOSIS. IT WAS REPORTED THAT THE PATIENT DEVELOPED RADIATING PAIN SECONDARY TO SEVERE LEFT FORAMINAL STENOSIS AT L5/S1 AND DEGENERATIVE LEFTWARD TILT AT L5/S1. MRI ON (B)(6) 2023: FACET ARTHROPATHY, LIGAMENTUM THICKENING, MODERATE CENTRAL CANAL STENOSIS, SEVERE RIGHT AND MODERATELY SEVERE LEFT FORAMINAL NARROWING AT L5/ S1. L2/L3 MODERATELY SEVERE CENTRAL STENOSIS, MODERATE BILATERAL FORAMINAL STENOSIS. THE PATIENT IS SCHEDULED FOR REMOVAL OF HARDWARE AT L3/L5 WITH TLIF AT L2/L3 AND L5/S1 AND POSTERIOR FUSION L2/S1. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL ACTION TAKEN: L5/S1 ESI ORDERED. THE AE RESULTED IN ADDITIONAL TREATMENT WITH PHYSIATRIST. OUTCOME STATUS: RECOVERING/RESOLVING. THE PATIENT UNDERWENT DIAGNOSTICS TEST OF MRI WITH CONTRAST2 ON (B)(6) 2023. ACTION RESULT: L2/L3 AND L5/S1 CENTRAL AND FORAMINAL STE NOSIS. THE PATIENT UNDERWENT DIAGNOSTICS TEST OF X-RAY1 ON (B)(6) 2023. ACTION RESULT: UPPER LUMBAR MILD SPONDYLOSIS. SITE RELATED ASSESSMENT: THE EVENT IS PROBABLY RELATED TO CAPSTONE PE

  Patient problems: Pain; Stenosis

  MAUDE report 18127917 ↗
• InjuryNov 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT IS DUPLICATE AND HENCE IT IS BEING UPDATED TO NON-REPORTABLE.

  Patient problems: Neuropathy

  MAUDE report 18109735 ↗
• InjuryNov 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT IS DUPLICATE AND HENCE IT IS BEING UPDATED TO NON-REPORTABLE.

  Patient problems: Neuropathy

  MAUDE report 18109694 ↗
• InjuryNov 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH CLINICAL ID (B)(6) AND STUDY ID (B)(6). DESCRIPTION: ADJACENT LEVEL DEGENERATION AT L2-L3 ONSET DATE: (B)(6) 2022 INTERVENTIONS: ACTION SUBTYPE: AE RESULT IN HOSPITALIZATION; ACTION RESULT: Y ACTION DATE: (B)(6) 2023, END DATE OF THE HOSPITALIZATION: (B)(6) 2023 ACTION SUBTYPE: DRUG THERAPY; ACTION RESULT: YES ACTION SUBTYPE: SURGICAL TREATMENT; ACTION RESULT: YES OUTCOME STATUS: NOT RECOVERED/NOT RESOLVED DIAGNOSTICS ACTION TYPE: ACTION SUBTYPE: X-RAY1 ACTION RESULT: MILD LUMBAR DEXTROSCOLIOSIS, ACTION DATE: (B)(6) 2022 ACTION SUBTYPE: MRI WITHOUT CONTRAST2 ACTION RESULT: STENOSIS, ACTION DATE: (B)(6) 2023 ACTION SUBTYPE: WERE ANY DIAGNOSTIC TEST PERFORMED ACTION RESULT: Y COMMENTS: ADVERSE EVENT INFO: DOES THE ADVERSE EVENT INVOLVE A LUMBOSACRAL SPINAL LEVEL: YES; LEVELS INVOLVED: L2-L3 ADD SURGICAL PROC DATE - (B)(6) 2023 DETAILS SURG PROC - TLIF L2/L3 AND L5/S1, POSTERIOR INSTRUMENTATION REMOVAL AT L3/L5 WITH POSTEROLATERAL ARTHRODESIS, SEGMENTAL INST RUMENTATION AT L2/S1. IS THE ADDITIONAL SURGICAL PROCEDURE AN ELECTIVE REMOVAL - YES, ADJACENT LEVELS TLIF AND SEGMENTAL INSTRU

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

  MAUDE report 18099023 ↗
• MalfunctionMay 27, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN INDICATION OF L4-5 DISC HERNIATION IN NEED OF L4-5 TLIF IN SPINAL THERAPY. IT WAS REPORTED THAT THE SURGEON INSERTED THE CAPSTONE AND USED THE HAMMER HITTING THE INSERTER TWO TIMES, THEN THE CAPSTONE IMPLANT WAS BROKEN. THE SURGEON REMOVED ALL THE FRAGMENT OF CAPSTONE AND REPLACED THE NEW ONE. THERE WAS A DELAY OF ABOUT 20 MINS REPORTED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FRAGMENTS IN THE PATIENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11891989 ↗
• MalfunctionNov 12, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS OF DISC DEGENERATIVE DISEASE. IT WAS REPORTED THAT INTRA-OP, WHEN CAGE WAS PUT ON THE CAGE HOLDER AND PUNCH INTO THE L4-5, THE CAGE BROKE AT THE CAGE HOLDER AND CAGE CONNECT PLACE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10827915 ↗
• MalfunctionNov 2, 2020Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF AT L5/S1 DUE TO L5/S1 SPONDYLOSIS AND FORAMINAL STENOSIS. IT WAS REPORTED THAT CAGE'S PART THAT INSERTER HOLD HAD BROKEN AND REMAINED ON THE INSERTER WHEN THE INSERTER WAS TAKEN OFF THE BODY. THE CAGE REMAINS IMPLANTED. DATE OF IMPLANT IS (B)(6) 2020. THERE WERE NO PATIENT SYMPTOMS/ COMPLICATIONS AS A RESULT OF THE EVENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10769522 ↗
• MalfunctionMay 22, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL INTERBODY LUMBAR FUSION (TLIF) SURGERY AT L2-3 DUE TO DEGENERATIVE DISC DISEASE (DDD). INTRA-OP, CAGE WAS BROKEN WHILE PLACEMENT OF THE SPACER, THE BROKEN FRAGMENT WAS REMOVED. THERE ARE NO PATIENT SYMPTOMS AT THIS TIME AS A RESULT OF THE CAGE BREAKAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8631189 ↗
• InjuryJul 17, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT PATIENT WITH STENOSIS UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION AT LEVELS L2-L5.ON AN UNKNOWN DATE, POST-OP, THE IMPLANTED CAGE BACKED OUT. THE PATIENT DEVELOPED NEUROLOGICAL SYMPTOM AS A RESULT OF THIS EVENT. HENCE, THE CAGE WAS REMOVED AND FIXATION RANGE WAS EXTENDED TO L2. NO COMPLICATIONS WERE REPORTED AFTER THIS SURGERY.

  Patient problems: Neurological Deficit/Dysfunction; No Code Available

  MAUDE report 6716579 ↗
• InjuryMar 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANT DATE: (B)(6) 2010 (MONTH AND YEAR VALID) IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, PATIENT SUFFERED WITH SEVERE SCALP ACNE, ALLERGIC REACTION AND WORSENING OF ASTHMA. PATIENT STATED SHE WAS AWARE OF NICKEL ALLERGY PRIOR TO THE SURGERY.

  Patient problems: No Code Available

  MAUDE report 6375594 ↗
• InjuryNov 23, 2016Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L3/4/5 ON (B)(6) 2014. ON AN UNKNOWN DATE, POST-OP, NEUROLOGICAL SYMPTOM WAS OBSERVED AS CAGES BACKED OUT DUE TO UNSUCCESSFUL BONE UNION. REVISION SURGERY IS SCHEDULED.

  Patient problems: Neurological Deficit/Dysfunction; No Code Available

  MAUDE report 6123603 ↗
• InjuryNov 23, 2016Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L3/4/5 ON (B)(6) 2014. ON AN UNKNOWN DATE, POST-OP, NEUROLOGICAL SYMPTOM WAS OBSERVED AS CAGES BACKED OUT DUE TO UNSUCCESSFUL BONE UNION. REVISION SURGERY IS SCHEDULED.

  Patient problems: Neurological Deficit/Dysfunction; No Code Available

  MAUDE report 6123602 ↗