MectaLIF Anterior 03.30.302Recalls & reported problems
Medacta International SA · MectaLIF Ant - Lag Plate Flush H14 mm · Class 2 · Implant
All models of MectaLIF Anterior (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630345732309), received between Oct 30, 2025 and Oct 30, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
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 16, 2026.
Reports received per month
Recalls naming this device
- Mar 8, 2023Class IICompleted
There is a potential for breakage of the small screw used to affix the anti-backout plate.
Z-1402-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 30, 2025Fracture; Fracture
DURING PRIMARY SPINAL SURGERY AT L4-5, THE FIXED ANGLE AWL BROKE OFF IN THE BONE, THE SURGEON PULLED IT OUT AND USED A DIFFERENT FIXED ANGLE AWL TO MAKE THE HOLE FOR THE SCREW. SURGICAL STEPS PERFORMED: DISCECTOMY, TRIAL, MECTALIF IMPLANT, AWL FOR SCREW HOLES, SCREWS INSERTION AND THE COVER PLATE PLACEMENT. NO TAPPING/DRILLING PERFORMED. DURING CAUDAL SCREW INSERTION, THE SCREWDRIVER BROKE, AND A BACKUP SCREWDRIVER WAS REQUIRED. ADDITIONALLY, WHILE ATTACHING THE ANTI-BACKOUT LAG PLATE, THE ANTI-BACKOUT SCREW ON THE COVER PLATE BROKE OFF WHEN BEING TIGHTENED BY THE TORQUE LIMITER. IT WAS NOTED THAT THE BONE WAS SCLEROTIC, AND THE SURGEON DETERMINED THERE WAS NO RISK OF SCREW BACKOUT. THE BROKEN PORTION OF THE SCREW REMAINED IN THE ANTERIOR PLATE, PREVENTING THE PLACEMENT OF ANOTHER COVER PLATE. THE SURGERY WAS COMPLETED WITHOUT THE COVER PLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23424083 ↗
Other Intervertebral Fusion Device With Integrated Fixation, Lumbar devices
- PIVOX™ Oblique Lateral Spinal System 2161001Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, lumbar182 reports
- IdentiTi 232-10-85-300Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall8 reports
- IdentiTi 232-10-85-250Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall5 reports
- IdentiTi 132-10-85-300Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall3 reports
- IdentiTi 232-10-85-350Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall2 reports
- MectaLIF Anterior 03.30.301Medacta International SA · Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall2 reports
- IdentiTi 232-11-90-350Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall1 report
- MectaLIF Anterior 03.30.300Medacta International SA · Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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