MectaLIF Anterior 03.30.301Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630345732293), received between Mar 9, 2023 and Mar 9, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Mar 8, 2023Class IICompleted

   There is a potential for breakage of the small screw used to affix the anti-backout plate.

   Z-1401-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• MalfunctionMar 9, 2023Fracture; Fracture

  DURING THE PRIMARY SPINE SURGERY, WHILE THE SURGEON WAS TIGHTENING THE ANTI BACK OUT LAG COVER PLATE, THE SURGEON THOUGHT HE HAD LOCKED THE PLATE. THE SURGEON THEN REMOVED THE PLATE HOLDER ALONG WITH THE DRIVER AND THE SURGEON THEN NOTICED THAT THE ANTIBACKOUT COVER PLATE WAS STILL ATTACHED TO THE PLATE HOLDER. THE SURGEON ALSO OBSERVED THAT THE TOP OF THE SCREW HAD BROKEN OFF FROM THE THREADED PORTION. THE SURGEON LEFT THE THREADED PORTION OF THE SCREW IN THE PLATE AND CONTINUED WITH THE CASE. NO POSTERIOR FIXATION PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16511523 ↗
• MalfunctionMar 9, 2023Fracture; Fracture

  DURING THE PRIMARY SPINE SURGERY, WHEN THE SURGEON WAS ADDING THE ALIF ANTI-BACKOUT LAG PLATE, THE TORQUE LIMITER HANDLE DID NOT GIVE OFF A "CLICK" SOUND TO INDICATE WHEN TO STOP TORSIONAL PRESSURE/FORCE. AS A RESULT, THE SURGEON KEPT TRYING TO SCREW IN THE FACEPLATE AND THE ANTIBACKOUT SCREW BROKE IN HALF. THE DISTAL TIP OF THE ANTIBACKOUT SCREW COLD-FUSED INTO THE FACEPLATE. THE SURGEON LEFT THE 4 PRIMARY SCREWS AS THEY WERE AND COMPLETED THE CASE WITHOUT THE ANTIBACKOUT PLATE. THE SURGEON PERFORMED A POSTERIOR FIXATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16511522 ↗