CAPSTONE CONTROL™ Spinal System 4001522Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 4001522 6 DEG 15X22 · 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 00643169109582), received between Nov 17, 2017 and Nov 17, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Migration or Expulsion of Device1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 17, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, SPACER EJECTED/MIGRATED AT L5-S1. SPACER PROGRESSIVELY DISLODGED POSTERIORLY BEGINNING LESS THAN 1 MONTH FROM THE INITIAL SURGERY. RADIOGRAPHICALLY IDENTIFIED 4-5MM OF POSTERIOR MOVEMENT COMPARED WITH IMMEDIATE POS T-OPERATIVE FILMS ON (B)(6). AS A RESULT, PATIENT UNDERWENT REVISION ANTERIOR SURGERY. DISLODGED CAGE WAS SUCCESSFULLY REMOVED FROM THE ANTERIOR APPROACH AND THE L5-S1 LEVEL WAS RE-IMPLANTED WITH A AN INTERBODY SPACER AND PLATE. PATIENT IS CURRENTLY STABILIZED AND RECOVERING WELL FOLLOWING REVISION SURGERY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7040856 ↗
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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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