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Anteralign Spinal System with Titan nanoLock Surface technology 46221055Recalls & reported problems

Medtronic Sofamor Danek, Inc. · NANO SPACER 46221055 12DG 20W 10X5.8X55 · Class 2 · Implant

Data updated Oct 18, 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 00763000128791), received between Feb 23, 2023 and Feb 23, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (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 18, 2026.

Most reported problems

Device problems

  • Migration1
  • Use of Device Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 23, 2023Use of Device Problem; Migration; Use of Device Problem; Migration

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A CAGE, BONE SCREW AND MINIPLATE USED FOR CONTINUED USE. IT WAS REPORTED THAT THE CAGE INSERTED INTO L4/5 HAS BACKED OUT. LEVELS IMPLANTED WAS L3/4, L4/5. IT WAS ALSO UNDERSTOOD THAT PATIENT WAS SUFFERING ADULT SPINAL DEFORMITY. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED. CAGE WAS IMPLANTED AT THE SURGERY ON JANUARY 25 FOR L3/4 AND L4/5, AND BACK-OUT WAS DETECTED IN L4/5 ON (B)(6). ON (B)(6), REOPERATION WAS PERFORMED AND THE CAGE WAS REMOVED AND A SLIGHTLY LARGER SIZE WAS PLACED AGAIN WITHOUT A MINI PLATE. POSTERIOR FIXATION WAS ADDED, AND THE OPERATION WAS COMPLETED SUCCESSFULLY. A REAR FIXATION WAS ADDED. THEIR WAS ALSO A HUMAN ERROR IN THE EVENT. ALSO, BONE SCREW AND MINIPLATE WERE ATTACHED AND IMPLANTED WITH THE REPORTED CAGE ON (B)(6). BOTH MINIPLATE AND BONE SCREW MIGRATED ALONG WITH THE CAGE. IN THE REVISION OP ON (B)(6), THE CAGE WAS REMOVED WITH THE BONE SCREW AND MINIPLATE, AND THEN A LITTLE LARGER CAGE WAS IMPLANTED WITHOUT MINIPLATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16425390 ↗

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Sources and updates

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