Anteralign Spinal System with Titan nanoLock Surface technology 46221260Recalls & reported problems
Medtronic Sofamor Danek, Inc. · NANO SPACER 46221260 12DG 20W 12X7.8X60 · 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 00763000128852), received between Dec 1, 2023 and Dec 1, 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.
Reports received per month
Most reported problems
Device problems
- Migration1
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.
InjuryDec 1, 2023Migration; Migration
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAGNOSIS FOR LCS. PROCEDURE PERFORMED WAS OLIF THERAPY. THE LEVEL AT WHICH THE IMPLANT PERFORMED WAS L3/4/5. IT WAS REPORTED THAT THE CAGE CAME OUT, SO IT WAS INSERTED AGAIN. TWO INTERVERTEBRAL OLIF WAS PERFORMED ON (B)(6), 2023. INSERTED CAGE INTO L3/4 AND DD WAS INSERTED IN L4/5. THE REAR PART WAS FIXED WITH V5. THE AG FOR L3/4 CAME OUT, AND THE L3 SCREW LOOSENED. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. PATIENT NEED TO BE HOSPITALIZED OR STAY LONGER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18244510 ↗
Other Intervertebral fusion device with integrated fixation, lumbar devices
- PIVOX™ Oblique Lateral Spinal System 2161001Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, lumbar182 reports
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- IdentiTi 232-10-85-250Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall5 reports
- IdentiTi 132-10-85-300Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall3 reports
- MectaLIF Anterior 03.30.301Medacta International SA · Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall2 reports
- IdentiTi 232-10-85-350Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall2 reports
- IdentiTi 232-11-90-350Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall1 report
- MectaLIF Anterior 03.30.302Medacta International SA · Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall1 report
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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