ONCONTROL IPN919025Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841156108564), received between May 8, 2023 and Jun 29, 2023 — classified as 2 injuries.

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. 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.

• InjuryJun 29, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT: THE DISTAL PIECE OF THE ON CONTROL BIOPSY CANNULA BROKE OFF IN A PATIENT'S SKULL DURING A BONE BIOPSY. NO MEDICAL OR SURGICAL INTERVENTION WAS PERFORMED. IT WAS REPORTED THAT THE PATIENT WAS FINE POST THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17224899 ↗
• InjuryMay 8, 2023Break; Break

  IT WAS REPORTED THAT: LESION NEEDLE BROKE OFF IN PATIENTS' BONE DURING AN OSTEOID OSTEOMA BONE BIOPSY. THE PHYSICIAN STATES HE THOUGHT THE NEEDLE BENT WHEN TRYING TO GET THE BIOPSY SAMPLE AND THE DRIVER WOULD NOT SPIN TO DRIVE IN OR OUT. ADDITIONAL INFORMATION: THE ESTIMATED LENGTH OF THE DEVICE EMBEDDED IN THE PATIENT'S LEG BONE WAS 1-2CM, THE BONE WAS REPORTED AS BEING SCLEROTIC. THE ORTHOPAEDIC SURGEON PULLED OUT THE FRAGMENT AND THE PATIENT WAS DESCRIBED AS FINE POST THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16884412 ↗