AVAmax VMX00CTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403002113), received between Apr 20, 2018 and Apr 20, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2018Break; Detachment Of Device Component; Difficult to Remove

  PATIENT WAS HAVING A VERTEBROPLASTY. RADIOLOGIST WAS ATTEMPTING TO REPOSITION THE VERTEBRAL AUGMENTATION NEEDLE TO ADD ADDITIONAL CEMENT AND THE NEEDLE WOULD NOT MOVE. RADIOLOGIST MADE MULTIPLE ATTEMPTS TO REMOVE AND THEN TRIED TO REMOVE WITH THE USE OF HEMOSTATS AND THEN THE NEEDLE BROKE OFF WITH APPROXIMATELY 2 - 2.5 INCHES ABOVE PATIENT'S SKIN. RADIOLOGIST CONTACTED AN INTERVENTIONAL RADIOLOGIST TO DISCUSS CASE. PLANS TO TRANSFER THE PATIENT TO SVI FOR REMOVAL ON THE NEXT MORNING. THE NEEDLE ENTRY SITE WAS PADDED WITH A NEEDLE COVER AND DRESSED. PATIENT WAS GIVEN ANTIBIOTICS PROPHYLACTICALLY. PATIENT PROCEDURE WAS PERFORMED AT SAINT VINCENT INFIRMARY IN LITTLE ROCK, AR AND INTERVENTIONAL RADIOLOGIST WAS ABLE TO REMOVE THE ENTIRE NEEDLE REMAINING IN THE PATIENT (B)(6) 2018. T11 VERTEBRAL FRACTURE WAS REASON FOR THE PROCEDURE. ROUTE: INTRAVERTEBRAL. IS THE PRODUCT COMPOUNDED: NO. IS THE PRODUCT OVER-THE-COUNTER: NO.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7450559 ↗