CAPSTONE CONTROL™ Spinal System 4001427Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 4001427 6 DEG 14X27 · Class 2 · Implant
Data updated Oct 13, 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 00643169109827), received between Mar 6, 2017 and Mar 6, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Migration or Expulsion of Device1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 6, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT ON (B)(6) 2013, THE PATIENT SUFFERED FROM A CONDITION IN HIS LOWER BACK WHICH REQUIRED STABILIZATION OF HIS SPINE. AS A RESULT OF PATIENT'S MEDICAL CONDITION, DOCTOR INSTALLED HARDWARE INTO HIS BACK WHICH INCLUDED TITANIUM SCREWS. POST-OP, ON (B)(6) 2014 (DATE IS APPROX.), TWO OF THE TITANIUM SCREWS BROKE CAUSING THE HARDWARE INSTALLED TO BECOME LOOSE AND DESTABILIZE THE SPINE AND PAIN TO THE PATIENT. ALLEGEDLY, THE PATIENT UNDERWENT REVISION SURGERY FOR INSTALLATION OF NEW HARDWARE AND TITANIUM SCREWS.
Patient problems: No Code Available
MAUDE report 6379649 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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