StabiliT® 00884450390467Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450390467), received between Mar 3, 2021 and Jun 22, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2021Material Fragmentation; Material Deformation; Material Fragmentation; Material Deformation

  THE ACCOUNT ALLEGES DURING A POSTERIOR HARDWARE REMOVAL PROCEDURE THE ACCESS NEEDLE BENT AND BROKE OFF IN THE BONE. THE FOREIGN BODY REMAINED WITHIN THE PATIENT. NO PATIENT HARM TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12046746 ↗
• InjuryMar 3, 2021Material Separation; Material Separation

  THE ACCOUNT ALLEGES THAT WHEN ATTEMPTING TO CREATE A PERCUTANEOUS ACCESS CHANNEL INTO THE VERTEBRAL BODY DURING A KYPHOPLASTY PROCEDURE, THE DEVICE DETACHED WHEN TRYING TO REMOVE IT FROM THE PATIENT'S SPINE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND THE FOREIGN BODY REMAINED WITHIN THE PATIENT. AN ADDITIONAL SURGICAL PROCEDURE MAY BE NECESSARY TO REMOVE THE FOREIGN BODY. NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 11405819 ↗