Anteralign Spinal System with Titan nanoLock Surface technology 4675020Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000508791), received between Nov 17, 2022 and Aug 21, 2025 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 8 most recent of 8 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 WHE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22858094 ↗
• InjuryMar 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED THAT SURGEONS WERE ABLE TO ACCESS TO THE INSTRUMENTED LEVEL AND USED THE ANTERALIGN SCREWDRIVER TO EXTRACT THE SCREW WITHOUT ANY ISSUE ON 3/28.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21502376 ↗
• MalfunctionFeb 25, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE SCREW HAS BACKED OUT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE PROCEDURE WAS ANTERIOR LUMBAR INTERBODY FUSION (ALIF). THE SCREW FROM THE SPACER HAS BACKED OUT. THE EVENT OCCURRED INTRA -OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21456504 ↗
• InjurySep 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING L 3/4 OLIF PROCEDURE IN A PATIENT DIAGNOSED WITH L3/4/5 LCS. IT WAS REPORTED THAT THE OPERATION WAS PERFORMED IN THE FIRST PERIOD, IN WHICH THE OLIF 2 INTERVERTEBRAL AND POSTERIOR FUSIONS WERE DIVIDED INTO TWO PERIODS. THE FIRST TERM WAS COMPLETED BY INSERTING A CAGE, PLATE & SCREW BETWEEN THE 2 INTERVERTEBRAL OF L3/4/5. THE SECOND PERIOD OF POSTERIOR FIXATION WAS PERFORMED WITH NON-MEDTRONIC HARDWARE. BETWEEN THE FIRST AND SECOND PERIOD, ABOUT ONE-THIRD OF THE L3/4 CAGE CAME OFF IN ONE WEEK. THE CAGE THAT HAD COME LOOSE WAS TO BE DRIVEN IN AGAIN, SO ONLY THE SCREWS IN THE PLATE WERE REMOVED, THE PLATE AND CAGE WERE DRIVEN IN AS THEY WERE, FITTED BETWEEN THE VERTEBRAE, AND FINISHED AFTER COMPRESSION WAS APPLIED AT THE TIME OF POSTERIOR FIXATION. THERE WAS A DELAY OF LESS THAN 60 MINS. 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 20205831 ↗
• InjuryJul 11, 2024Difficult to Insert; Difficult to Insert

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH SPACER AND SCREW HAVING L4/5,5/S OBLIQUE LATERAL INTERBODY FUSION (OLIF) THERAPY FOR LUMBAR SPINAL STENOSIS. IT WAS REPORTED THAT L4/5 CLYESDALE PTC SPACER WAS INSTALLED WITHOUT ANY ISSUES AND L5/S WAS APPROACHED THROUGH A SEPARATE INCISION. THE PROCEDURE PROGRESSED SMOOTHLY UNTIL THE RETRACTOR WAS PLACED, AND THE CAGE WAS INSTALLED WITH 12 DEGREES. A PILOT HOLE WAS CREATED, AND THE BONE SCREW WAS INSERTED. HOWEVER, THE SCREW DID NOT GO IN SMOOTHLY, AND THE PROCESS OF CREATING A PILOT HOLE AND INSERTING THE SCREW WAS REPEATED SEVERAL TIMES. THE DIRECTION OF THE SCREW DID NOT ALIGN WITH THE CAGE'S SCREW HOLE, SO THE SCREW WAS REINSERTED USING THE INSERTER AS A GUIDE, AND THE SCREW WAS EVENTUALLY INSTALLED SUCCESSFULLY. UPON REMOVING THE SCREWDRIVER, BLEEDING FROM THE LEFT COMMON ILIAC ARTERY WAS OBSERVED. HEMOSTASIS WAS ACHIEVED BY APPLYING A TACHOSIL AND COMPRESSING FOR ABOUT 15 MINUTES. FINALLY, SURGIFLO WAS USED TO ENSURE HEMOSTASIS, THE AREA WAS IRRIGATED, AND IT WAS CONFIRMED THAT THERE WAS NO FURTHERBLEEDING BEFORE CLOSING THE WOUND. BECAUSE THE ISSUE WA

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19717147 ↗
• InjuryMay 1, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L5-S1 ANTERIOR LUMBAR INTERBODY FUSION FOR AN INDICATION OF DEGENERATIVE DISC DISEASE AND SPINAL STENOSIS. IT WAS REPORTED THAT THE ANTERALIGN LS SCREW THAT WAS PLACED AROUND (B)(6) 2023 HAS DISLODGED (BACK-OUT) FROM THE ANTERALIGN LS SPACER. AN ADDITIONAL ANTERIOR EXPOSURE WITH ADDITIONAL SURGERY IS PLANNED TO REMOVE THE LOOSE SCREW IN NEAR FUTURE. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19218858 ↗
• InjuryFeb 24, 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 JANUARY 27. ON JANUARY 30, 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 25TH JAN. BOTH MINIPLATE AND BONE SCREW MIGRATED ALONG WITH THE CAGE. IN THE REVISION OP ON JAN/30, 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 16437449 ↗
• InjuryNov 17, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT PREVIOUSLY IMPLANTED WITH A CAGE-PLATE-SCREW CONSTRUCT IN AN OLIF FOR LEVELS 3-4 FOR ANOTHER MECHANICAL COMPLICATION. IT WAS REPORTED THAT THE ORIGINAL SURGERY WAS OLIF 3-5 ON (B)(6) 2022. THE 3-4 CAGE BACKED OUT. ON (B)(6) 2022, THEY REVISED BY PUSH IN THE CAGE AND ADDING THE INTEGRATED PLATE AND SCREW. ON PREVIOUS REVISION THE CAGE WAS INSPECTED AND NEW BIOLOGICAL GRAFT WAS USED. THE IMPLANT BACKED OUT PRIOR TO FUSION. ON (B)(6) 2022, THE PATIENT CAME TO CLINIC AND SHOWED THAT THE CAGE/PLATE/SCREW CONSTRUCT BACKED OUT. THE PRODUCTS WERE REPLACED WITH AN ALTERNATE DEVICE AND ADDITIONAL FIXATION. THE PATIENT IS ASYMPTOMATIC. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15821666 ↗