StabiliT® 00884450315903Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450315903), received between Oct 31, 2024 and Oct 31, 2024 — classified as 1 injury.
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 16, 2026.
Reports received per month
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.
InjuryOct 31, 2024Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES DURING THE PROCEDURE WHEN REMOVING THE WORKING CANNULA. THE CANNULA BROKE OFF INSIDE OF THE BONE IN THE PEDICEL. A FOLLOW PROCEDURE WILL BE NEEDED WITH A SPINE SURGEON TO REMOVE THE BROKEN PIECE. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 20578360 ↗
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- SYNFLATE 03.804.701SSynthes GmbH · CEMENT, BONE, VERTEBROPLASTY60 reports
- KYPHON® HV-R® Bone Cement C01AMedtronic Sofamor Danek, Inc. · CEMENT, BONE, VERTEBROPLASTY57 reports
- iVAS 0705315000Stryker Corporation · CEMENT, BONE, VERTEBROPLASTY1 recall3 reports
- Cortoss 2101-0005Stryker Corporation · CEMENT, BONE, VERTEBROPLASTY1 recall3 reports
- iVAS 0705310000Stryker 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 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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