STALIF L STL5514-00Recalls & reported problems
Centinel Spine, LLC · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815101022321), received between Feb 6, 2017 and Jun 2, 2017 — classified as 2 injuries.
The most frequently reported specific device problem is “Malposition of Device” (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
- Adverse Event Without Identified Device or Use Problem2
- Malposition of Device1
Patient problems
- Discomfort1
- Neurological Deficit/Dysfunction1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 2, 2017Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem
A STALIF C DEVICE IMPLANTED AROUND (B)(6) 2016 WAS REQUIRED TO BE REVISED ON (B)(6) 2017. THE PATIENT HAD BEEN EXPERIENCING DISCOMFORT AND ON A FOLLOW UP X-RAY IT WAS NOTED THAT THE IMPLANT WAS OFF MIDLINE. THE SURGEON HAD FELT THAT THE IMPLANT WAS NOT THE CAUSE OF THE PROBLEM, IT WAS THE POOR POSITIONING. AS OF (B)(6) 2017, NO FOLLOW UP INFORMATION HAD BEEN RECEIVED AND THE COMPLAINT IS STILL OPEN PENDING FURTHER COMMUNICATION.
Patient problems: Discomfort
MAUDE report 6609530 ↗InjuryFeb 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER INFORMATION TO REPORT.
Patient problems: Neurological Deficit/Dysfunction
MAUDE report 6306074 ↗
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
- IdentiTi 232-10-85-350Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall2 reports
- 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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