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CAPSTONE CONTROL™ Spinal System 4001227Recalls & reported problems

Medtronic Sofamor Danek, Inc. · SPACER 4001227 6 DEG 12X27 · 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
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169109766), received between Oct 27, 2017 and Oct 27, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

  • Break1

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.

  • MalfunctionOct 27, 2017Break; Break

    IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L3/4 AND L4/5. DURING SURGERY, SPACER IMPLANTED AT L4-L5 WAS BROKEN. THERE ARE FRAGMENTS OF SPACER AT L4-5 STILL INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED. NO REVISION SURGERY WAS SCHEDULED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6982690 ↗

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Sources and updates

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