MectaLIF Anterior System 03.30.132Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030875427), received between May 25, 2018 and Jul 5, 2019 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• InjuryJul 5, 2019Fracture; Fracture

  SCREW BREAKAGE AFTER ABOUT 1 YEAR FROM PRIMARY SURGERY. NO REVISION SURGERY HAS BEEN PERFORMED FOR THE MOMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8764307 ↗
• MalfunctionMay 10, 2019Device Slipped

  THE SURGEON DISCOVERED THAT ONE OF THE SCREW BACKED OUT. THE SURGEON DOESN'T REVISE THE SCREW BUT HE IS MONITORING THIS PATIENT TO UNDERSTAND IF THE SCREW IS CONTINUING TO BACK-OUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8599631 ↗
• MalfunctionNov 19, 2018Break; Detachment of Device or Device Component

  FROM THE FINAL PER-OP X-RAYS THE SURGEON DETECTED THAT THE PLATE WAS PROUD BY 1MM FROM THE ANTERIOR PORTION OF THE VERTEBRAL BODY. HE PROCEEDED TO USE THE FIXED STRAIGHT SCREW DRIVER TO BRING THE PLATE DOWN AND BY OVERNIGHTING THE SCREW, THE HEAD SHEARED OFF. THERE WERE NO FRAGMENTS, IT WAS A CLEAN BREAK. THE SCREW SHANK WAS LEFT IN PLACE, BURIED/COUNTERSUNK IN THE CAGE/BONE. THE BROKEN SCREW HEAD WAS REMOVED. NO DEFORMATION OR BREAKAGE OF THE INSTRUMENTS OCCURRED. THERE WERE A FIVE MINUTES OF DELAY IN THE CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8084558 ↗
• MalfunctionSep 20, 2018Break; Break

  THE PATIENT COMPLAINED OF BACK PAIN ON (B)(6) 2018 AND WAS SENT FOR X-RAYS (L5/S1 ALIF PROCEDURE). THIS SHOWED BOTH S1 SCREWS HAD BROKEN. THE SURGEON HAS DECIDED NOT TO REVISE THIS AND ALSO TO CHANGE HIS TECHNIQUE TO INCLUDE DRILLING AND ALSO MORE X-RAYS DURING PROCEDURE TO ENSURE NO GAP. HE IS SATISFIED THAT THE CAGE IS FUSING WELL AND THAT THE PAIN IS NOT COMING FROM THIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7893365 ↗
• InjuryMay 25, 2018Break

  THE PATIENT HAD A PRIMARY ALIF AT L5-S1. THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THAT THE SCREW BROKE. THERE IS CURRENTLY NO PLAN TO REVISE THE PATIENT.

  Patient problems: Pain

  MAUDE report 7544747 ↗