iVAS 0705315000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613252505969), received between Nov 19, 2018 and Jan 28, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Nov 9, 2017Terminated

   Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

   Z-1254-2018 · Root cause: Environmental control · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2020Break; Fracture; Break; Fracture

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE FRACTURED. 1 EVENT HAD A SMALL PIECE OF THE DEVICE LEFT BEHIND IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 9636485 ↗
• InjuryAug 21, 2019Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING VERTEBRAL AUGMENTATION THE ACCESS CANULA BROKE WHILE PULLING OUT OF THE VERTEBRAL BODY. AN ADDITIONAL PROCEDURE WAS NEEDED TO REMOVE THE DEVICE MATERIAL LEFT BEHIND. NO FURTHER ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 8915455 ↗
• MalfunctionNov 19, 2018Material Rupture

  THE PATIENT WAS HAVING KYPHOPLASTY PROCEDURE OF THEIR L1 VERTEBRA (1ST LUMBAR) WHERE THE PROVIDER GETS ACCESS TO THE VERTEBRAL THROUGH PEDICLE USING A NEEDLE AND HAMMER. AFTER GETTING ACCESS TO THE VERTEBRAL BODY REMOVING THE INNER STYLET OF THE NEEDLE, BUT BEFORE INJECTING THE CEMENT, THE PROVIDER WILL INFLATE A BALLOON INSIDE THE VERTEBRAL BODY TO CREATE MORE SPACE FOR THE CEMENT. THE BALLOON IS INFLATED WITH CONTRAST (ISOVUE 300), AND WHILE INFLATING IT DURING THIS PROCEDURE, THE BALLOON POPPED. THE PATIENTS CHART DID NOT STATE ANY ALLERGY TO CONTRAST MEDIA. HOWEVER, THE PATIENT TOLD US PRIOR TO THE PROCEDURE THAT SHE HAD A CT SCAN WITH IV CONTRAST AND HAD A REACTION, ALTHOUGH SHE COULD NOT REMEMBER EXACTLY WHAT HER REACTION WAS. THIS WAS DISCUSSED PRE-PROCEDURE WILL ALL TEAM MEMBERS INVOLVED (PROVIDER, NURSE, TECHS), SO EVERYONE WAS AWARE. THE PATIENT DID NOT HAVE ANY VISIBLE REACTION DURING THIS PROCEDURE AFTER THE BALLOON POPPED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8083858 ↗