CAPSTONE CONTROL™ Spinal System 4001127Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 4001127 6 DEG 11X27 · 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169109735), received between Feb 27, 2017 and Feb 27, 2017 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Neuropathy1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WITH LUMBAR SPINAL CANAL STENOSIS UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT L4-5 ON (B)(6) 2017. REPORTEDLY, ON (B)(6) 2017, POST-OP, RADICULAR SYMPTOMS ON RIGHT SIDE AT L5 WERE OBSERVED AFTER TLIF SURGERY AT L4-5. REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2017. REPORTEDLY PATIENT'S ROOT WAS MUCH THICKER THAN THE NORMAL PATIENT'S AND RUNS TRANSVERSELY. DURING REVISION SURGERY, ON (B)(6) 2017, ONLY DECOMPRESSION AT RIGHT SIDE WAS PERFORMED. THE SPACER DID NOT MALFUNCTION. ACCORDING TO SURGEON, THE LEFT SIDE OF VERTEBRAL BODY WAS LIFTED TOO MUCH, OR IT WAS DUE TO COMPRESSION TECHNIQUE.
Patient problems: Neuropathy
MAUDE report 6359904 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
- T-PAL 03.812.003Synthes GmbH · Intervertebral fusion device with bone graft, lumbar152 reports
- T-PAL 03.812.004Synthes GmbH · Intervertebral fusion device with bone graft, lumbar120 reports
- Catalyft PL Expandable Interbody System 6068073Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall66 reports
- Catalyft PL Expandable Interbody System 6069076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall51 reports
- Catalyft PL Expandable Interbody System 6068076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall46 reports
- 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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