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Axle Interspinous Fusion System X060-0241Recalls & reported problems

Xtant Medical Holdings, Inc. · Axle Locking Plate Assy, 36, No Insert · Class 2 · Implant

All models of Axle Interspinous Fusion System (7)

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 M697X06002411), received between May 28, 2020 and May 28, 2020 — 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.

Most reported problems

Device problems

  • Material Fragmentation1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 28, 2020Material Fragmentation; Material Fragmentation

    THE COMPANY RECEIVED NOTIFICATION ON 4/29/2020 REGARDING AN IMPLANT SET SCREW THAT FRACTURED WHEN IT WAS TIGHTENED DURING A SURGICAL PROCEDURE ON (B)(6) 2020. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS PRODUCT COMPLAINT. A SET SCREW FROM AN ALTERNATE IMPLANT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10099297 ↗

Other Spinous process plate devices

All Spinous process plate devices →

Sources and updates

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