CAPSTONE CONTROL™ Spinal System 4011227Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 4011227 12 DEG 12X27 · Class 2 · Implant
All models of CAPSTONE CONTROL Spinal System (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169108844), received between Jan 2, 2020 and Jul 30, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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
Device problems
- Break1
- Mechanics Altered1
Patient problems
- No Known Impact Or Consequence To Patient1
- Pain1
- Undesired Nerve Stimulation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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