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CAPSTONE CONTROL™ Spinal System 4011222Recalls & reported problems

Medtronic Sofamor Danek, Inc. · SPACER 4011222 12 DEG 12X22 · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169109070), received between Nov 17, 2017 and Sep 5, 2018 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (2 reports).

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

  • Migration2
  • Material Deformation1

Patient problems

  • No Known Impact Or Consequence To Patient3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjurySep 5, 2018Migration; Migration

    PRE-OPERATIVE DIAGNOSIS: SCOLIOSIS PROCEDURE: OBLIQUE LUMBAR INTERBODY FUSION (OLIF), PLIF WAS PERFORMED AT L5/S IT WAS REPORTED THAT POST-OP, THE CAGE MIGRATED. THE PATIENT UNDERWENT POSTERIOR REVISION SURGERY ON (B)(6) 2018 BUT NO INFORMATION WAS KNOWN OF THE REVISION.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7846831 ↗
  • InjurySep 5, 2018Migration; Migration

    PRE-OPERATIVE DIAGNOSIS: SCOLIOSIS PROCEDURE: OBLIQUE LUMBAR INTERBODY FUSION(OLIF), PLIF WAS PERFORMED AT L5/S IT WAS REPORTED THAT POST-OP, THE CAGE MIGRATED. THE PATIENT UNDERWENT POSTERIOR REVISION SURGERY ON (B)(6) 2018 BUT NO INFORMATION WAS KNOWN OF THE REVISION.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7846821 ↗
  • MalfunctionNov 17, 2017Material Deformation; Material Deformation

    PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: LUMBAR CANAL STENOSIS TYPE OF PROCEDURE USED: TRANSFORAMINAL LUMBAR INTERBODY FUSION LEVELS IMPLANTED: L5-S1 IT WAS REPORTED THAT DURING SURGERY, INSERTER CAME OFF FROM A CAGE DURING ROTATION. WHEN THE CAGE WAS PULLED OUT TO CONFIRM, IT WAS FOUND TO BE SLIGHTLY DEFORMED AND THE THREADS WERE BROKEN. THE CAGE WAS CHANGED TO ONE SIZE SMALLER CAGE, AND IT WAS PLACED WITHOUT PROBLEM. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7042446 ↗

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Sources and updates

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