Idys™- ALIF 24430014-SRecalls & reported problems
Clariance · ALIF PLATE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03700780627127), received between Aug 1, 2022 and Nov 16, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Insert” (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.
Reports received per month
Most reported problems
Device problems
- Difficult to Insert1
- Positioning Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 16, 2023Difficult to Insert; Difficult to Insert
SURGEON COULDN'T GET SCREW TO LOCK INTO PLATE DURING IMPLANTATION. UPON INSPECTION, THE LOCKING RING LOOKED FINE AND NOT DAMAGED AT ALL TO SURGEON. THE SURGEON OPTED TO NOT SWAP OUT THE PLATE AND JUST USE THREE SCREWS. HE CLEARED THE PLATE/SCREW INTERFACE AREA OF ANY DEBRIS AND THE SCREW STILL WOULDN'T LOCK. AT THIS POINT, IT WAS ADJUDGED BY THE SURGEON TO PROCEED WITH THREE SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18155303 ↗MalfunctionAug 1, 2022Positioning Problem; Positioning Problem
WHILE INSERTING A SCREW THROUGH THE PLATE, ONE OF THE PLATE'S LOCKING SLEEVES REMAINED SLIGHTLY PROUD OF THE PLATE, PREVENTING THE SCREW FROM SITTING FLUSH IN THE PLATE. THE SCREW WAS LEFT IN PLACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15138677 ↗
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
- MectaLIF Anterior 03.30.301Medacta International SA · Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall2 reports
- IdentiTi 232-10-85-350Alphatec Spine, Inc. · 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 03.30.302Medacta 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 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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