STALIF MIDLINE STM6025RRecalls & 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 00815101029320), received between Feb 19, 2020 and Feb 19, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Loss of Osseointegration1
- Migration1
Patient problems
- Spinal Column Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 19, 2020Loss of Osseointegration; Device Dislodged or Dislocated; Migration; Loss of Osseointegration; Device Dislodged or Dislocated; Migration
A PATIENT REQUIRED A REVISION SURGERY ON (B)(6) 2020 TO REMOVE 2 STALIF MIDLINE SCREWS WHICH HAD BACKED OUT OF THE L4-L5 STALIF M FLX CONSTRUCT DUE TO SUBSIDENCE OF THE CAGE INTO THE L5 VERTEBRAE. THE SCREW BACK OUT AND SUBSIDENCE WAS NOTED DURING ROUTINE POST-OPERATIVE FOLLOW-UP ON (B)(6) 2020. THE SURGEON ELECTED TO REMOVE THE SCREWS DUE TO THE AGGRESSIVE SCREW BACK OUT AND LOCATION TO BLOOD VESSELS TO PRECLUDE SERIOUS INJURY. IN ADDITION TO THE SCREW REMOVAL, POSTERIOR FIXATION WAS ADDED TO STABILIZE THE IMPLANT. THE PATIENT DID NOT PRESENT WITH ANY SIGNS OR SYMPTOMS RELATED TO THE SCREW BACK OUT AT THE FOLLOW-UP APPOINTMENT.
Patient problems: Spinal Column Injury
MAUDE report 9729218 ↗
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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