NA 0306130000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540434302), received between Nov 28, 2018 and Nov 28, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

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

Recent adverse event reports

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

• InjuryNov 28, 2018Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A VERTEBROPLASTY PROCEDURE, THAT THE PATIENT'S BLOOD PRESSURE DROPPED DUE TO THE PHYSICIAN CUTTING A NERVE. MEDICAL INTERVENTION WAS NECESSARY FOR A SMALL CHEST BLEED BY INSERTING A COIL TO PREVENT FURTHER BLEEDING. THE PATIENT WAS ADMITTED TO THE ICU. UPON FOLLOW UP, THE INITIAL REPORTER WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.

  Patient problems: Blood Loss; Nerve Damage

  MAUDE report 8111656 ↗
• InjuryNov 28, 2018Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A VERTEBROPLASTY PROCEDURE, THAT THE PATIENT'S BLOOD PRESSURE DROPPED DUE TO THE PHYSICIAN CUTTING A NERVE. MEDICAL INTERVENTION WAS NECESSARY FOR A SMALL CHEST BLEED BY INSERTING A COIL TO PREVENT FURTHER BLEEDING. THE PATIENT WAS ADMITTED TO THE ICU. UPON FOLLOW UP, THE INITIAL REPORTER WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.

  Patient problems: Blood Loss; Nerve Damage

  MAUDE report 8111555 ↗