Anteralign Spinal System with Titan nanoLock Surface technology 4675030Recalls & reported problems
Medtronic Sofamor Danek, Inc. · BONE SCREW 4675030 LS 5.0X30MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000508807), received between Aug 7, 2024 and May 15, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL REGARDING A PATIENT WHO WAS IMPLANTED WITH BONE SCREW. IT WAS REPORTED THAT DURING A FOLLOW-UP APPOINTMENT ON (B)(6), IT WAS OBSERVED IN THE LATERAL A SCREW IS BACKING OUT. NO PATIENT SYMPTOMS OR COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THERE IS NO REVISION SURGERY PLANNED TO EXPLANT AS OF NOW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22026583 ↗MalfunctionAug 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO HAD L5-S1 ALIF DUE TO DDD. IT WAS REPORTED THAT LS SCREW BACKED OUT OF CAGE AFTER BEING FINAL TIGHTENED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19929209 ↗
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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