CAPSTONE CONTROL Spinal SystemRecalls & reported problems across all models
Medtronic Sofamor Danek, Inc. · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls
- 0
We found 13 models of CAPSTONE CONTROL Spinal System by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Jan 13, 2017 and Jan 19, 2025 — classified as 11 injuries, 10 malfunctions.
The most frequently reported specific device problem is “Break” (10 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
Reports received per month, all models
Most reported CAPSTONE CONTROL Spinal System problems
Device problems
- Break10
- Migration or Expulsion of Device4
- Migration2
- Adverse Event Without Identified Device or Use Problem1
- Loose or Intermittent Connection1
- Malposition of Device1
- Material Deformation1
- Mechanics Altered1
Patient problems
- No Known Impact Or Consequence To Patient12
- No Code Available4
- Pain2
- Spinal Column Injury2
- Neuropathy1
- No Clinical Signs, Symptoms or Conditions1
- Undesired Nerve Stimulation1
CAPSTONE CONTROL Spinal System models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CAPSTONE CONTROL™ Spinal System 4011022Intervertebral fusion device with bone graft, lumbar3 reports
- CAPSTONE CONTROL™ Spinal System 4011222Intervertebral fusion device with bone graft, lumbar3 reports
- CAPSTONE CONTROL™ Spinal System 4011227Intervertebral fusion device with bone graft, lumbar2 reports
- CAPSTONE CONTROL™ Spinal System 4011327Intervertebral fusion device with bone graft, lumbar2 reports
- CAPSTONE CONTROL™ Spinal System 4011122Intervertebral fusion device with bone graft, lumbar2 reports
- CAPSTONE CONTROL™ Spinal System 4001027Intervertebral fusion device with bone graft, lumbar2 reports
- CAPSTONE CONTROL™ Spinal System 4011422Intervertebral fusion device with bone graft, lumbar1 report
- CAPSTONE CONTROL™ Spinal System 4021322Intervertebral fusion device with bone graft, lumbar1 report
- CAPSTONE CONTROL™ Spinal System 4021522Intervertebral fusion device with bone graft, lumbar1 report
- CAPSTONE CONTROL™ Spinal System 4001522Intervertebral fusion device with bone graft, lumbar1 report
- CAPSTONE CONTROL™ Spinal System 4001127Intervertebral fusion device with bone graft, lumbar1 report
- CAPSTONE CONTROL™ Spinal System 4001227Intervertebral fusion device with bone graft, lumbar1 report
- CAPSTONE CONTROL™ Spinal System 4001427Intervertebral fusion device with bone graft, lumbar1 report
Recent CAPSTONE CONTROL Spinal System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJan 19, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR SPINAL STENOSIS. IT WAS REPORTED THAT, THE CAGE WAS BROKEN. THE PROCEDURE OR TECHNIQUE PERFORMED WAS TRANSFORAMINAL LUMBAR INTERBODY FUSION. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AND NO ADDITIONAL TREATMENT OR SURGERY PERFORMED. THERE WERE NO BROKEN FRAGMENTS OF IMPLANT REMAINS IN PATIENT BODY. THERE WAS NO DELAY IN PROCEDURE REPORTED AS A RESULT AND THE REPORTED PRODUCT WAS LOST AFTER SENDING IT FOR WASH. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21187830 ↗InjuryJul 30, 2021Mechanics Altered; Mechanics Altered
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING PATIENT SPINAL THERAPY FOR SAGITAL IMBALANCE. IT WAS REPORTED THAT WHEN THE SURGEON TRIED TO IMPLANT THE CAGE AND TURN IT IN ORDER TO TAKE THE FINAL POSITION, THE IMPLANT RELEASED FROM THE INSERTER AND AS RESULT THE IMPLANT DIDN¿T IMPLANTED ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELLING. THERE WAS PATIENT HAD SCIATICA PAIN, NERVE COMPRESSION AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Pain; Undesired Nerve Stimulation
MAUDE report 12252355 ↗MalfunctionJan 2, 2020Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY DUE TO NON-UNION. INTRA-OP, THE IMPLANT BROKE ON INSERTION AT L2-L3. THE BROKEN IMPLANTED WAS COMPLETELY EXPLANTED; AND WAS REPLACED WITH A NEW ONE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9539420 ↗MalfunctionJan 2, 2020Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY DUE TO NON-UNION. INTRA-OP, THE IMPLANT BROKE ON INSERTION AT L2-L3. THE BROKEN IMPLANTED WAS COMPLETELY EXPLANTED; AND WAS REPLACED WITH A NEW ONE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9539419 ↗InjuryOct 9, 2018Break; Break
PRE-OPERATIVE DIAGNOSIS: L4/5 SPONDYLOLISTHESIS PROCEDURE: POSTERIOR LUMBAR INTERBODY FUSION/ ADDITIONAL TRANSFORAMINAL LUMBAR INTERBODY FUSION LEVELS IMPLANTED: L4/5 IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, CAGE BROKE AND PATIENT SUFFERED WITH ADJACENT SEGMENTAL DISEASE. AN ADDITIONAL SURGERY FOR EXTENSION TO THE UPPER SEGMENT WAS PLANNED.
Patient problems: Spinal Column Injury
MAUDE report 7946263 ↗InjuryOct 9, 2018Break; Break
PRE-OPERATIVE DIAGNOSIS: L4/5 SPONDYLOLISTHESIS PROCEDURE: POSTERIOR LUMBAR INTERBODY FUSION/ ADDITIONAL TRANSFORAMINAL LUMBAR INTERBODY FUSION LEVELS IMPLANTED: L4/5 IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, CAGE BROKE AND PATIENT SUFFERED WITH ADJACENT SEGMENTAL DISEASE. AN ADDITIONAL SURGERY FOR EXTENSION TO THE UPPER SEGMENT WAS PLANNED.
Patient problems: Spinal Column Injury
MAUDE report 7946262 ↗MalfunctionSep 11, 2018Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION (PLIF) SURGERY DUE TO SPINAL CANAL STENOSIS. INTRA-OP, WHEN THE CAGE WAS HAMMERED, IT WAS FOUND THAT THE LOCK WAS LOOSE. IT WAS ATTEMPTED TO BE TIGHTENED BUT IT SEEMED THAT THE THREAD WAS BROKEN AND IT COULD NOT BE LOCKED. NO PATIENT'S SYMPTOMS AND COMPLICATION WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7863626 ↗InjurySep 5, 2018Migration; Migration
PRE-OPERATIVE DIAGNOSIS: SCOLIOSIS PROCEDURE: OBLIQUE LUMBAR INTERBODY FUSION (OLIF), PLIF WAS PERFORMED AT L5/S IT WAS REPORTED THAT POST-OP, THE CAGE MIGRATED. THE PATIENT UNDERWENT POSTERIOR REVISION SURGERY ON (B)(6) 2018 BUT NO INFORMATION WAS KNOWN OF THE REVISION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7846831 ↗InjurySep 5, 2018Migration; Migration
PRE-OPERATIVE DIAGNOSIS: SCOLIOSIS PROCEDURE: OBLIQUE LUMBAR INTERBODY FUSION(OLIF), PLIF WAS PERFORMED AT L5/S IT WAS REPORTED THAT POST-OP, THE CAGE MIGRATED. THE PATIENT UNDERWENT POSTERIOR REVISION SURGERY ON (B)(6) 2018 BUT NO INFORMATION WAS KNOWN OF THE REVISION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7846821 ↗MalfunctionJun 8, 2018Break; Break
IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH DEGENERATIVE DISC DISEASE AND UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4-5. DURING SURGERY, THE SPACER BROKE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS OF THE BROKEN PART REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7581324 ↗MalfunctionJun 8, 2018Break; Break
IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH DEGENERATIVE DISC DISEASE AND UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4-5. DURING SURGERY, THE SPACER BROKE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS OF THE BROKEN PART REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7581317 ↗MalfunctionFeb 15, 2018Break; Break
IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH FAILURE OF BONE FUSION OCCURRED DUE TO LOOSENING OF THE POSTERIOR SCREW AND UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION (OLIF) AT L3,L4,L5. DURING SURGERY, WHEN REMOVING THE CAGE BY PERFORMING OLIF, THE MARKER OF CAGE WAS BROKEN. FRAGMENTS OF THE BROKEN PART REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7272521 ↗MalfunctionNov 17, 2017Material Deformation; Material Deformation
PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: LUMBAR CANAL STENOSIS TYPE OF PROCEDURE USED: TRANSFORAMINAL LUMBAR INTERBODY FUSION LEVELS IMPLANTED: L5-S1 IT WAS REPORTED THAT DURING SURGERY, INSERTER CAME OFF FROM A CAGE DURING ROTATION. WHEN THE CAGE WAS PULLED OUT TO CONFIRM, IT WAS FOUND TO BE SLIGHTLY DEFORMED AND THE THREADS WERE BROKEN. THE CAGE WAS CHANGED TO ONE SIZE SMALLER CAGE, AND IT WAS PLACED WITHOUT PROBLEM. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7042446 ↗InjuryNov 17, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, SPACER EJECTED/MIGRATED AT L5-S1. SPACER PROGRESSIVELY DISLODGED POSTERIORLY BEGINNING LESS THAN 1 MONTH FROM THE INITIAL SURGERY. RADIOGRAPHICALLY IDENTIFIED 4-5MM OF POSTERIOR MOVEMENT COMPARED WITH IMMEDIATE POS T-OPERATIVE FILMS ON (B)(6). AS A RESULT, PATIENT UNDERWENT REVISION ANTERIOR SURGERY. DISLODGED CAGE WAS SUCCESSFULLY REMOVED FROM THE ANTERIOR APPROACH AND THE L5-S1 LEVEL WAS RE-IMPLANTED WITH A AN INTERBODY SPACER AND PLATE. PATIENT IS CURRENTLY STABILIZED AND RECOVERING WELL FOLLOWING REVISION SURGERY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7040856 ↗MalfunctionOct 27, 2017Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L3/4 AND L4/5. DURING SURGERY, SPACER IMPLANTED AT L4-L5 WAS BROKEN. THERE ARE FRAGMENTS OF SPACER AT L4-5 STILL INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED. NO REVISION SURGERY WAS SCHEDULED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6982690 ↗
Other Medtronic Sofamor Danek, Inc. products
- CD HORIZON Spinal System342 models · 2,323 reports
- GRAFTONand GRAFTON PLUSDemineralized Bone Matrix (DBM)25 models · 12 reports · 14 recalls
- METRx System5 models · 672 reports
- INFUSE Bone Graft6 models · 576 reports · 1 recall
- CD HORIZON SOLERA VOYAGER Spinal System60 models · 411 reports
- POWEREASE Instruments8 models · 331 reports · 1 recall
- Catalyft PL Expandable Interbody System16 models · 279 reports · 1 recall
- INFINITY Occipitocervical Upper Thoracic System35 models · 63 reports · 5 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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