AVAflex 1031120000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327374582), received between Aug 27, 2019 and Apr 24, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16802078 ↗
• MalfunctionOct 24, 2022Fracture; Fracture

  THIS REPORT SUMMARIZES: 2 MALFUNCTION EVENTS. IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 2 EVENTS, HAD PATIENT INVOLVEMENT. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15663664 ↗
• InjuryOct 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING CEMENT INJECTION OF AN L3 KYPHOPLASTY, AFTER THE SURGEON SPOT-FILLED CLEFTED AREAS IN THE VERTEBRAL BODY, THE CURVED NEEDLE COULD NOT BE REMOVED. ATTEMPTS TO GRASP THE NEEDLE WITH A HEMOSTAT RESULTED IN THE NEEDLE BREAKING. THE PROCEDURE WAS COMPLETED WITH AN APPROXIMATE 1-HOUR DELAY DURING WHICH THE NEEDLE WAS SURGICALLY CUT DOWN AS CLOSE TO THE EXIT POINT OF THE PEDICLE AS POSSIBLE. NO OTHER MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15579010 ↗
• InjuryAug 27, 2019Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT THE CURVED INJECTION NEEDLE BECAME STUCK IN THE PATIENT'S BACK. MEDICAL INTERVENTION WAS NECESSARY AS IT WAS REPORTED THAT THE PHYSICIANS HAD TO DISSECT TO THE BONE AND CUT OFF THE NEEDLE FLUSH AT THE BONE LEAVING THE PORTION THAT WAS STUCK IN THE PATIENT'S BODY. THE REMAINDER OF THE NEEDLE WAS LEFT BEHIND IN THE PATIENT. NO FURTHER ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 8934608 ↗