StabiliT MX Fracture Kit MX-1100L-01Recalls & reported problems
Dfine, Inc. · 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 00850696006615), received between Feb 27, 2020 and Feb 27, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
- Material Separation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2020Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT POST-KYPHOPLASTY PROCEDURE, THE STEERABLE VERTEBRAL AUGMENTATION SYSTEM BECAME STUCK WITHIN THE PATIENT SPINE DURING REMOVAL. IT WAS NOTED THAT ONLY THE TIP OF THE VERTEBRAL AUGMENTATION DEVICE HAD DETACHED WITHIN THE PATIENT'S PEDICLE. NO CHANCE OF MIGRATION OR PATIENT INJURY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED TO HOME AS EXPECTED. NO PLANS TO REMOVE THE FOREIGN BODY.
Patient problems: Foreign Body In Patient
MAUDE report 9767423 ↗
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- KYPHON® Xpede™ Bone Cement and KYPHON® Mixer Pack CX01BMedtronic Sofamor Danek, Inc. · CEMENT, BONE, VERTEBROPLASTY3 deaths67 reports
- SYNFLATE 03.804.701SSynthes GmbH · CEMENT, BONE, VERTEBROPLASTY60 reports
- KYPHON® HV-R® Bone Cement C01AMedtronic Sofamor Danek, Inc. · CEMENT, BONE, VERTEBROPLASTY57 reports
- Cortoss 2101-0005Stryker Corporation · CEMENT, BONE, VERTEBROPLASTY1 recall3 reports
- iVAS 0705315000Stryker Corporation · CEMENT, BONE, VERTEBROPLASTY1 recall3 reports
- Cortoss 2101-0010Stryker Corporation · CEMENT, BONE, VERTEBROPLASTY1 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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