SP-FIX 188.044Recalls & reported problems
Globus Medical, Inc. · SP-Fix Locking Plate, 44mm · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00849044091649), received between Jun 14, 2022 and Jun 14, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 14, 2022Break; Migration
IT WAS REPORTED THAT A PATIENT'S SPINOUS PROCESS BROKE POST-OPERATIVELY. SUBSEQUENTLY, SP-FIX IMPLANT HAS MIGRATED. THIS EVENT OCCURRED IN GERMANY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14689188 ↗
Other Spinous process plate devices
- CoFix Implant 10 mm RQI00010Paradigm Spine GmbH · Spinous Process Plate1 report
- Axle Interspinous Fusion System X060-0080Xtant Medical Holdings, Inc. · Spinous process plate1 report
- ROMEO 2 PAD POSTERIOR AXIAL DEVICE PAD-IM TI 08-SSpineArt SA · Spinous Process Plate1 report
- ZIP LPAurora Spine, Inc. · Spinous Process Plate1 report
- ZIP LPAurora Spine, Inc. · Spinous Process Plate1 report
- Axle Interspinous Fusion System X060-0241Xtant Medical Holdings, Inc. · Spinous process plate1 report
- UniVise 48590035Stryker Corporation · Spinous process plate1 report
- SP-FIX 588.026Globus Medical, Inc. · Spinous process plate1 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 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