Idys®-LLIF 3DTi 51430013-SRecalls & reported problems
Clariance · LLIF 3DTi Plate · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03700780634521), received between Jun 14, 2021 and Jun 14, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Disconnection” (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 16, 2026.
Most reported problems
Device problems
- Disconnection1
- Entrapment of Device1
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.
MalfunctionJun 14, 2021Disconnection; Entrapment of Device
SURGEON INSERTED THE CAGE + PLATE ASSEMBLY. HE WAS UNHAPPY WITH THE CAGE POSITION. HE DECIDED TO REMOVE THE CAGE + PLATE ASSEMBLY. WHILE EXTRACTING THE CAGE + PLATE ASSEMBLY AND USING SLAP-HAMMER, THE PLATE DISCONNECTED FROM CAGE. AS A RESULT, CAGE REMAINED IN THE DISC SPACE. AN INSTRUMENT AVAILABLE DURING SURGERY WAS USED TO REMOVE CAGE OUT OF THE DISC SPACE. THE SURGEON RE-INSERTED THE CAGE + PLATE ASSEMBLY AND THE PLATE DISCONNECTED AGAIN. AS A CONSEQUENCE, THE PRODUCT WAS USED WITHOUT PLATE. NO HARM WAS CAUSED TO THE PATIENT. AS ORIGINALLY PLANNED, A POSTERIOR FIXATION WAS USED TO BACK-UP THE CAGE. DELAY IN SURGERY WAS ABOUT 15 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11994829 ↗
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- 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 16, 2026
- 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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