CoFix Implant 10 mm RQI00010Recalls & reported problems
Paradigm Spine GmbH · Class 2 · Implant
Data updated Oct 18, 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 04260148898242), received between Oct 18, 2023 and Oct 18, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
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.
MalfunctionOct 18, 2023Material Fragmentation; Material Fragmentation
THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON (B)(6) 2023. IT WAS REPORTED THAT A FIXATION SCREW FROM A SYSTEM IMPLANT FRACTURED WHILE BEING FINAL TIGHTENED FOR IMPLANT PLACEMENT. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THIS COMPLAINT. AN ALTERNATE AVAILABLE FIXATION SCREW WAS USED TO SUCCESSFULLY COMPLETE THE SURGICAL PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17961975 ↗
Other Spinous Process Plate devices
- Axle Interspinous Fusion System X060-0080Xtant Medical Holdings, Inc. · Spinous process plate1 report
- UniVise 48590035Stryker Corporation · Spinous process plate1 report
- ROMEO 2 PAD POSTERIOR AXIAL DEVICE PAD-IM TI 08-SSpineArt SA · Spinous Process Plate1 report
- Axle Interspinous Fusion System X060-0241Xtant Medical Holdings, Inc. · Spinous process plate1 report
- ZIP ULTRAAurora Spine, Inc. · Spinous Process Plate1 report
- ZIP LPAurora Spine, Inc. · Spinous Process Plate1 report
- ZIP LPAurora Spine, Inc. · 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 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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