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StabiliT® 00884450379851Recalls & reported problems

Merit Medical Systems, Inc. · Class 2

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 00884450379851), received between Apr 9, 2020 and Apr 9, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Fracture1

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.

  • MalfunctionApr 9, 2020Fracture; Fracture

    THE ACCOUNT ALLEGES DURING A VERTEBRAL AUGMENTATION PROCEDURE, THE TIP OF THE AUGMENTATION SYSTEM DETACHED WITHIN THE PATIENTS VERTEBRAL BODY AND WAS NOT REMOVED. THE DETACHED TIP WAS CEMENTED IN PLACE AND THE PROCEDURE COMPLETED WITHOUT ANY ADDITIONAL CONSEQUENCES TO THE PATIENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9945997 ↗

Other CEMENT, BONE, VERTEBROPLASTY devices

All CEMENT, BONE, VERTEBROPLASTY devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.