CAPSTONE Spinal SystemRecalls & reported problems across all models

We found 21 models of CAPSTONE Spinal System by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 73 adverse event reports in the FDA's MAUDE database, received between Nov 21, 2016 and Sep 29, 2026 — classified as 31 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Break” (26 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported CAPSTONE Spinal System problems

CAPSTONE Spinal System models

21 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CAPSTONE® Spinal System 2991026

  Intervertebral fusion device with bone graft, lumbar
  14 reports
• CAPSTONE® Spinal System 2991022

  Intervertebral fusion device with bone graft, lumbar
  10 reports
• CAPSTONE® Spinal System 2991226

  Intervertebral fusion device with bone graft, lumbar
  9 reports
• CAPSTONE® Spinal System 2990822

  Intervertebral fusion device with bone graft, lumbar
  8 reports
• CAPSTONE® Spinal System 2991222

  Intervertebral fusion device with bone graft, lumbar
  4 reports
• CAPSTONE® Spinal System 2991432

  Intervertebral fusion device with bone graft, lumbar
  3 reports
• CAPSTONE® Spinal System 2990826

  Intervertebral fusion device with bone graft, lumbar
  3 reports
• CAPSTONE® Spinal System 2990926

  Intervertebral fusion device with bone graft, lumbar
  3 reports
• CAPSTONE® Spinal System 2991126

  Intervertebral fusion device with bone graft, lumbar
  3 reports
• CAPSTONE® Spinal System 2991426

  Intervertebral fusion device with bone graft, lumbar
  2 reports
• CAPSTONE® Spinal System 2991232

  Intervertebral fusion device with bone graft, lumbar
  2 reports
• CAPSTONE® Spinal System 2990622

  Intervertebral fusion device with bone graft, lumbar
  2 reports
• CAPSTONE® Spinal System 2991326

  Intervertebral fusion device with bone graft, lumbar
  2 reports
• CAPSTONE® Spinal System 2991632

  Intervertebral fusion device with bone graft, lumbar
  1 report
• CAPSTONE® Spinal System 2991626

  Intervertebral fusion device with bone graft, lumbar
  1 report
• CAPSTONE® Spinal System 2991422

  Intervertebral fusion device with bone graft, lumbar
  1 report
• CAPSTONE® Spinal System 2990932

  Intervertebral fusion device with bone graft, lumbar
  1 report
• CAPSTONE® Spinal System 2990722

  Intervertebral fusion device with bone graft, lumbar
  1 report
• CAPSTONE® Spinal System 2991122

  Intervertebral fusion device with bone graft, lumbar
  1 report
• CAPSTONE® Spinal System X01042610

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  1 report
• CAPSTONE® Spinal System X0605267

  Intervertebral fusion device with bone graft, lumbar
  1 report

Recent CAPSTONE Spinal System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Loosening of Implant Not Related to Bone-Ingrowth

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932503 ↗
• 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 ↗
• MalfunctionJun 26, 2026Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT HAVING RANSFORAMINAL LUMBAR INTERBODY FUSION FOR A PRIMARY DIAGNOSIS OF SPINAL INSTABILITY. IT WAS REPORTED THAT THE PATIENT HAS UNDERWENT TREATMENT AT TWO CONSECUTIVE LEVELS FROM L2¿S1 AND SUBSEQUENT IMAGING ANALYSIS IDENTIFIED HARDWARE LOOSENING INVOLVING A SCREW, ROD AND SPACER. PATIENT SYMPTOMS, OUTCOMES, AND PATIENT IMPACT WERE REPORTED AS UNKNOWN, AND ADDITIONAL MEDICAL INTERVENTION TO PREVENT PERMANENT INJURY OR IMPAIRMENT WAS REPORTED AS UNKNOWN. NO ASSESSMENT OF PRODUCT, THERAPY, OR PROCEDURE RELATEDNESS WAS MADE BY THE INVESTIGATOR, SPONSOR, OR CEC. ADDITIONAL INFORMATION WAS RECEIVED THAT THE IMAGING ANALYSIS DID NOT IDENTIFY WHICH SURGICAL COMPONENT WAS LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25635738 ↗
• 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 ↗
• MalfunctionNov 19, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT IMPLANTED WITH SPACER HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) THERAPY FOR L3-L4 HERNIATED INTERVERTEBRAL DISC AND GRADE 2 SPONDYLOLISTHESIS. IT WAS REPORTED THAT AFTER TRIALING, THE SURGEON FULLY INSERTED THE CAGE. WHEN ATTEMPTING TO IMPACT THE CAGE FURTHER INTO POSITION, THE SURGEON NOTED THAT THE CAGE HOLDER HAD DETACHED FROM THE CAGE. THE SURGEON REMOVED THE IMPLANT AND ASSOCIATED FRAGMENTS COMPLETELY. A NEW CAGE WAS THEN OPENED, IMPLANTED, AND THE PROCEDURE WAS COMPLETED UNEVENTFULLY, NO PATIENT SYMPTOM WERE REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23592113 ↗
• 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 ↗
• 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 ↗
• MalfunctionJan 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT USED IN L5-S1 POSTERIOR DECOMPRESSION AND INSTRUMENTED FUSION WITH TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SPINAL THERAPY FOR SPINAL STENOSIS. IT WAS REPORTED THAT WHEN SURGEON WANTED TO BRING BACK THE CAGE BY 2MM AND WAS TAPPING THE CAGE OUT WITH THE INSERTER HANDLE AND A MALLET. THE INSERTER SEEMED TO LET GO AND WHEN IT WAS PULLED OUT OF THE PATIENT, THE PIECE THAT THREADS ON WAS STILL ATTACHED TO THE CAGE AND THE END OF THE CAGE REMAINED. X-RAY WAS TAKEN AND THE CAGE APPEARED TO BE IN THE RIGHT SPACE, SO NO INTERVENTIONS WERE CARRIED TO RETRIEVE THAT PIECE OUT OF THE PATIENT THERE ARE NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE WERE NO ISSUES WITH THE INSERTER. IT WAS ENGAGED WITH THE CAGE PROPERLY AND NO CONCERNS WERE VOICED BY THE SURGEON. NO REVISION SURGERY TO BE PERFORMED AT THIS TIME AND THE REMAINING PART OF THE CAGE WAS DISCARDED BY STAFF.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21236959 ↗
• MalfunctionJan 21, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL(HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED IN POSTERIOR LUMBAR INTERBODY FUSION SURGERY (PLIF). IT WAS REPORTED THAT THERE WERE TWO TARGET SEGMENTS, AND WHEN THE SECOND CAPSTONE WAS APPLIED, THE FLUOROSCOPY FOUND THAT THE DEPTH OF THE CAPSTONE WAS NOT IDEAL. THE CAPSTONE WAS ATTEMPTED TO BE TAKEN OUT, AND DURING THE REMOVAL WITH A SLIDE HAMMER, THE POSTERIOR EDGE OF THE CAPSTONE WAS BROKEN. LATER, REPLACED WITH A NEW CAPSTONE TO USE AND THE SURGERY WAS COMPLETED. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE WAS LUMBAR SPINAL STENOSIS. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT BODY. THERE WAS A DELAY OF ABOUT 15 MINUTES IN THE OVERALL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21196977 ↗
• 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 ↗
• MalfunctionNov 29, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING OPEN AND DECOMPRESSED REDUCTION AND INTERNAL FIXATION FOR LUMBAR DISC HERNIATION. IT WAS REPORTED THAT THE SPACER DAMAGED DURING THE SOLERA4.75 SURGERY. THE SPACER BROKE AND THERE WERE NO FRAGMENTS OF THE IMPLANTS OR INSTRUMENTS REMAINED IN THE PATIENT'S BODY. THERE WERE NO ADDITIONAL SURGICAL OR MEDICAL INTERVENTION DONE AS A RESULT OF THIS EVENT. THE CAGE DAMAGED DURING IMPLANTATION AND IT REPLACED DURING THE SAME SURGERY. PRODUCT WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20810698 ↗
• 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 ↗
• 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 ↗

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