Anteralign Spinal System with Titan nanoLOCK Surface Technology 4675125Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000911027), received between Jun 9, 2025 and Jun 16, 2026 — classified as 1 injury, 1 malfunction.

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2026Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A SCREW USED FOR SPINAL THERAPY. IT WAS REPORTED THAT DURING AN ANTERALIGN CONSTRUCT PROCEDURE AT L4-5, TWO OF THE 5.0 X 25 MM TROCAR TIP BONE SCREW (THE INFERIOR SCREW INTO L5) OUT OF SIX USED WAS BACKING OUT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED, AND THE PATIENT OUTCOME WAS ALIVE WITH NO INJURY. NO REPLACEMENT WAS PERFORMED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED THAT INITIAL HOSPITALIZATION WASN'T PROLONGED, HOWEVER A SECOND PROCEDURE TO SUPPLEMENT ANTERIOR FIXATION WAS PERFORMED ON (B)(6) 2026. A POSTERIOR L4-S1 INSTRUMENTED FUSION WITH VOYAGER IMPLANT SYSTEM WAS PERFORMED. THE PROCEDURE INVOLVED WAS L4-S1 ALIF WITH ANTERALIGN LS IMPLANT SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25514429 ↗
• MalfunctionJun 9, 2025Migration; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING REMOVAL OF PREV IOUS SOLERA 4.75 INSTRUMENTATION FROM L2-5, ALIF L5-S1, OLIF L2-3, T10-PELVIS PEDICLE SCREW ROD FIXATION, L1-2 AND L2-3 LAMINECTOMY. IT WAS REPORTED THAT THE RADIOGRAPHIC IMAGING REVEALED THAT THE S1 SCREW HAD BACKED OUT OF THE VERTEBRAL BODY AND IMPLANT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22165050 ↗