MIDLINE II-Ti M331112cRecalls & reported problems
Centinel Spine, LLC · 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 00815101021331), received between May 4, 2021 and May 4, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Biocompatibility” (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
- Biocompatibility1
- Osseointegration Problem1
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.
InjuryMay 4, 2021Biocompatibility; Osseointegration Problem; Biocompatibility; Osseointegration Problem
A PATIENT RECEIVED A STALIF MIDLINE II-TI CAGE AND STALIF MIDLINE SCREWS ON (B)(6) 2019. THE ALIF PROCEDURE RESULTED IN A FAILED FUSION AND CONTINUED PATIENT PAIN. THE PATIENT UNDERWENT SURGICAL INTERVENTION TO ADD POSTERIOR FUSION ON AN UNKNOWN DATE. ACCORDING TO THE INFORMATION FROM THE PATIENT, THE SURGEON INFORMED THE PATIENT THAT THE FAILED FUSION MAY BE DUE TO THE PEEK MATERIAL USED TO MAKE THE CAGE. THE PATIENT ALSO SUSPECTS THEY HAVE AN ALLERGY TO METALS USED IN THE IMPLANTS. AS OF THIS REPORT, THE ALLERGY COULD NOT BE CONFIRMED DESPITE THE PATIENT UNDERGOING A IMPLANT MATERIAL ALLERGY PANEL.
Patient problems: Pain
MAUDE report 11771828 ↗
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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