Anteralign Spinal System with Titan nanoLock Surface technology 46260855Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000128449), received between Jun 14, 2023 and Aug 21, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Migration” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2025Use of Device Problem; Use of Device Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING PATIENT HAVING L4/5, L5/S OLIF DUE TO ISOLATION. LEVEL IMPLANTED WAS L4/5, L5/S. IT WAS REPORTED THAT THE COMMON ILIAC VEIN WAS DAMAGED AND A LARGE AMOUNT OF HEMORRHAGING OCCURRED WHICH MAY LEAD TO DEATH OR DISABILITY. BLEEDING WAS OBSERVED GRADUALLY AFTER THE L5/S IMPLANT WAS INSERTED AND ATTEMPTED TO STOP THE BLEEDING WITH THE HEMOSTATIC AGENT FLOSEAL AND SURGE FLOW, BUT HEMOSTASIS COULD NOT BE ACHIEVED. WHEN THE WOUND RETRACTOR WAS REMOVED, A LARGE AMOUNT OF HEMORRHAGING WAS OBSERVED AND THE BLEEDING WAS SUPPRESSED WITH GAUZE, BUT HEMOSTASIS COULD NOT BE ACHIEVED, SO A SURGEON FROM CARDIOVASCULAR SURGERY WAS CONTACTED TO COME. THE POSITION WAS CHANGED FROM LATERAL TO SUPINE AND THEN SWITCHED TO THE CARDIOVASCULAR SURGEON, THE BLEEDING SITE IS SPECIFIED AND THEN SUTURED TO STOP THE BLEEDING. BLOOD PRESSURE DROPPED TO 50 MIDWAY, BUT RECOVERED. ACCORDING TO THE CARDIOVASCULAR SURGEON, VEIN WAS PUSHED SLIGHTLY, BUT IT WOULD PROBABLY BE OKAY. THE PATIENT MIGHT EXPERIENCE SWELLING AFTER THE SURGERY, BUT IT WILL RETURN TO NORMAL. ACCORDING TO THE SURGEON, THE BLEEDING GRADUALLY OCCURRED WH

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22858103 ↗
• InjuryOct 28, 2024Off-Label Use; Migration; Off-Label Use; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING OLIF FOR ADULT SPINAL DEFORMITY. IT WAS REPORTED THAT THE PHYSICIAN RECOGNIZED THAT IT WAS AN OFF-LABEL USE, AND ONLY THE ANTERIOR FIXATION WAS PERFORMED USING THE OLIF APPROACH ON (B)(6) 2024. ANTERALINE WAS USED IN L1-5. ON (B)(6), IT WAS CONFIRMED VIA IMAGES THAT THE L4/5 CAGE HAD FALLEN OUT DURING CT IMAGING. ON (B)(6), THE CAGE WAS REINSERTED AGAIN (ADDITIONAL INSERTION WAS PERFORMED AGAIN) AND THE POSTERIOR FIXATION T10-S2 WAS FIXATED AT PPS. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20542371 ↗
• MalfunctionFeb 8, 2024Migration; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR LUMBAR DEGENERATIVE SCOLIOSIS. IT WAS REPORTED THAT, BACKWARD AVERSION OF AG BETWEEN L3 AND L4 OCCURRED. PROCEDURE OR TECHNIQUE PERFORMED WAS ANTERIOR L2-L5 OLIF POSTERIOR T10-IL FIXATION. THERE WERE NO PATIENT SYMPTOMS REPORTED, NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED. THE CAGE WAS DEFLECTED BACKWARDS BETWEEN L3/L4 LEVEL. EVENT WAS HAPPENED DURING USE. THERE WAS NO REVISION SURGERY IN PLAN TO RETRIEVE THE REPORTED CAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18665414 ↗
• MalfunctionJul 18, 2023Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAG NOSIS FOR LUMBAR SPINAL STENOSIS. PROCEDURE PERFORMED WAS L4/5 OLIF+PPS. LEVEL AT WHICH IMPLANT PERFORMED WAS L4/5. IT WAS REPORTED THAT DURING THE POSTOPERATIVE PATIENT VISIT, IT WAS DISCOVERED THAT THE CAGE PLACED DURING THE SURGERY BEGAN TO DISL ODGE/COME OUT. THERE WAS NO BONE FUSION. PATIENT FELT NUMBNESS IN THE LEFT LEG FELT. NO ANY TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. EXPLANTATION OR ADDITIONAL PLACEMENT WILL BE PERFORMED IF IF THE PATIENT'S SYMPTOM LASTS.

  Patient problems: Numbness

  MAUDE report 17347829 ↗
• MalfunctionJun 14, 2023Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING SPACERS USED IN OLIF THERAPY FOR LCS. LEVELS IMPLANTED: LUMBAR VERTEBRA IT WAS REPORTED THAT THE SPACER BACKED-OUT TO THE APPROACH SIDE. THE NANO-SPACER BACKED-OUT TO THE NON-APPROACH SIDE. THERE WAS NO ADDITIONAL SURGERY PLANNED AT THE MOMENT. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17123507 ↗