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MectaLIF Anterior System 03.30.131Recalls & reported problems

Medacta International SA · Enhanced Screw Diam.5x25 (Double Packaging) · Class 2 · Implant

All models of MectaLIF Anterior System (12)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030875410), received between Nov 22, 2017 and Apr 17, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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

Device problems

  • Fracture1
  • Material Deformation1

Patient problems

  • No Known Impact Or Consequence To Patient1
  • Pain1

Recent adverse event reports

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

  • InjuryApr 17, 2019Fracture; Fracture

    THE PATIENT CAME IN COMPLAINING OF PAIN WHICH WAS CAUSED BY A BROKEN MECTALIF ANTERIOR SCREW IN THE S1 VERTEBRAE AND THE CAUSE OF THE BROKEN SCREW IS UNKNOWN. THE SURGEON HAS NOT SCHEDULED A REVISION SURGERY AT THIS TIME.

    Patient problems: Pain

    MAUDE report 8522860 ↗
  • MalfunctionNov 22, 2017Material Deformation; Material Deformation

    DURING A FUSION OF L4-S1 THE SURGEON USED A STRAIGHT DRIVER TO PUT IN THE FIRST 2 SCREWS AT S1. THE SCREWS WENT IN WITH NO ISSUE. WHILE PUTTING 1ST SCREW INTO L5 THE ANGLE THE SURGEON WAS WORKING AT WAS NOT IDEAL. THE SURGEON TRIED PUTTING IN THE SCREWS AND APPLIED A LOT OF FORCE. SEVERAL SCREWS STRIPPED. ON HIS FINAL ATTEMPT AT ANOTHER SCREW THE STRAIGHT DRIVER BROKE INTO 3 PIECES. NO FRAGMENTS FELL INTO THE PATIENT. THE SURGEON USED A TORQUE DRIVER TO PUT IN ANOTHER SCREW. THE DRIVER SNAPPED IN HALF AND THE SCREW STRIPPED. THEN THE SURGEON USED ANOTHER COMPANY'S PLATE OVERTOP THE INTERBODY. TWO MEDACTA SCREWS AND ANOTHER COMPANY'S PLATE HELD THE INTERBODY IN PLACE AT L5-S1. THE SURGEON FUSED L4-L5 WITH A STRAIGHT DRIVER AND 4 SCREWS. NO ISSUED AT L4-L5. THE SURGERY WAS DELAYED APPROXIMATELY 90 MINUTES. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7052720 ↗

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Sources and updates

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