CAPSTONE CONTROL™ Spinal System 4011122Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 4011122 12 DEG 11X22 · 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169109063), received between Oct 9, 2018 and Oct 9, 2018 — classified as 2 injuries.
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
- Spinal Column Injury2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
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- EIT TLIF Inserter TFT30101EIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Lumbar88 reports
- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
- Catalyft PL Expandable Interbody System 6069096Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall25 reports
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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