Kyocera Medical Technologies, Inc. Tesera (REF 1033-383-013)Recalls & reported problems
Kyocera Medical Technologies, Inc. · Ti-6Al-4V ALIF Implant 38 x 30, 13mm 12° Lordosis · Class 2 · Implant
Data updated Oct 18, 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 00841523100675), received between Feb 1, 2019 and Feb 1, 2019 — classified as 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
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 1, 2019Fracture; Fracture
WHILE DISCUSSING THE CURRENT ALIF DESIGN WITH A SURGEON, THE SURGEON STATED THAT A PREVIOUS ALIF IMPLANT PATIENT HAD COMPLAINED OF PAIN IN (B)(6) 2018. UPON REVIEW OF A CURRENT X-RAY, THE SURGEON NOTICED THAT THE ALIF CAGE, IMPLANTED IN 2015, HAD FRACTURED. POST OP X-RAYS 1 YEAR POST-OP (2016) SHOWED THE CAGE STILL INTACT. THE PATIENT WAS DOING WELL UNTIL ABOUT A YEAR AGO. THE PATIENT STARTED EXPERIENCING SEVERE BACK PAIN ABOUT 2 WEEKS PRIOR TO THEIR VISIT ON (B)(6) 2018. THE CAGE FAILURE OCCURRED SOMETIME BETWEEN 2016 AND 2018.
Patient problems: Pain
MAUDE report 8299392 ↗
Other Intervertebral Fusion Device With Integrated Fixation, Lumbar devices
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- 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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