AxHA® AX143014Recalls & reported problems
INNO Holdings, Inc. · HA PEEK, Tantalum, Ti 6Al 4V ELI · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M711AX1430140), received between Mar 8, 2021 and Mar 8, 2021 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Abdominal Distention1
- Pain1
- Vertebral Fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 8, 2021Adverse Event Without Identified Device or Use Problem
ON (B)(6), 2021. INNOVASIS RECEIVED A PHONE CALL FROM DISTRIBUTOR (B)(4). INFORMING THAT DR. (B)(6) USED AN AX CAGE SEVERAL WEEKS AGO AND THE PATIENT HAS A VERTEBRAL BODY FRACTURE ON L5. IT WAS ALSO NOTED THAT NOTHING WENT WRONG WITH CAGE OR SYSTEM ITSELF. TIMELINE (B)(6) 2020 PATIENT SURGERY FOR BACK PAIN, L4 5-L4 5S1, LACK OF LORDOSIS. USED 2 CAGES WITH HIGH DEGREE OF LORDOSIS 14MM 14 CAGE AT L5S1, 16MM 20 AT L4-L5. PATIENT DEVELOPED OGILVIE SYNDROME BLOATING GI ISSUES POST OP ILEUS, REQUIRED MEDICAL TREATMENT 1 WEEK HOSPITALIZATION WHICH WENT WELL . CT SCAN FOR ILEUS SHOWS A LITTLE SETTLING OF THE IMPLANT. NOTE ILEUS NOT SPECIFIC TO IMPLANT DEVICE; RELATED TO ANY ABDOMINAL PROCEDURE. (B)(6) 2020, 2 WEEKS AFTER SURGERY SEVERE BACK PAIN, CT SCAN SHOWS A LOT MORE SETTLING SUBSIDENCE. (B)(6) 2020 REVISION SURGERY PERFORMED, POSTERIOR FIXATION. ONCE PEDICLE SCREWS WERE IMPLANTED THE SETTLING STOPPED. THE IMPLANT HAS MAXED OUT ON SUBSIDENCE, CAGE ALL THE WAY INTO THE VERTEBRAL BODY. REVISION HELPED PATIENT'S BACK PAIN AND SHE IS NOW DOING VERY WELL (B)(6) 2021.
Patient problems: Abdominal Distention; Pain; Vertebral Fracture
MAUDE report 11436174 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page