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CAPSTONE CONTROL™ Spinal System 4021522Recalls & reported problems

Medtronic Sofamor Danek, Inc. · SPACER 4021522 18 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 00643169109087), received between May 19, 2017 and May 19, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Malposition 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

  • Malposition 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.

  • InjuryMay 19, 2017Malposition of Device; Malposition of Device

    IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT PRESENTED WITH PRE-OP DIAGNOSIS AS: SPONDYLOLISTHESIS. FOR WHICH PATIENT UNDERWENT, FUSION AND TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT LEVELS L4-L5. INTRA-OP, THE CAGE WAS PLACED LATERALLY AND WENT THROUGH THE ANTERIOR LIGAMENT. THE CAGE WENT OFF THE INSERTER AND ENDED UP ANTERIORLY. THE PATIENT HAD TO UNDERGO ANTERIOR SURGERY TO GET THE CAGE OUT. THE INSERTER HAD NO MALFUNCTION. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: No Code Available

    MAUDE report 6577672 ↗

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Sources and updates

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