ELSA 1122.1050Recalls & reported problems
Globus Medical, Inc. · ELSA Spacer 20 x 50mm, 8-17mm, 5-20° · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889095334425), received between Mar 8, 2021 and Mar 1, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Collapse” (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.
Reports received per month
Most reported problems
Device problems
- Collapse1
- Human-Device Interface Problem1
- Inadequate User Interface1
Patient problems
- Insufficient Information2
- Spinal Column Injury1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 1, 2024Inadequate User Interface; Inadequate User Interface
IT WAS REPORTED THAT POST-OPERATIVELY THE ELSA CAGE LOST EXPANSION.
Patient problems: Insufficient Information
MAUDE report 18816751 ↗MalfunctionFeb 29, 2024Human-Device Interface Problem; Human-Device Interface Problem
IT WAS REPORTED THAT A REVISION WAS PERFORMED TO REPLACE AN ELSA SPACER 20 X 50MM, 8-17MM THAT WAS FOUND TO BE MIGRATING LATERALLY OUT OF THE IPSILATERAL DISC SPACE.
Patient problems: Spinal Column Injury
MAUDE report 18809810 ↗MalfunctionMar 8, 2021Collapse
IT WAS REPORTED THAT AN ELSA SPACER HAS COLLAPSED POST-OPERATIVELY. THERE ARE NO PLANS FOR A REVISION SURGERY.
Patient problems: Insufficient Information
MAUDE report 11440245 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page