CAPSTONE CONTROL™ Spinal System 4011327Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 4011327 12 DEG 13X27 · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169108851), received between Oct 27, 2017 and Jan 2, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
Device problems
- Break2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionOct 27, 2017Break; Break
IT WAS REPORTED THAT, PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L3/4 AND L4/5. DURING SURGERY, THE THREAD ON THE SPACER IMPLANTED ON THE L3-L4 LEVEL CAME OUT. NO PATIENT COMPLICATIONS WERE REPORTED WERE REPORTED AS A RESULT OF THE EVENT. NO REVISION WAS SCHEDULED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6982689 ↗
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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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