NA 03.809.874Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034726427), received between Oct 5, 2021 and Oct 5, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (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.

• MalfunctionOct 5, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, A PATIENT WAS TREATED WITH AN ORACLE IMPLANT AT THE HEIGHT OF L4/5. DURING THE SURGERY, THE IMPLANT CRACKED ON THE IMPLANT HOLDER. A DIFFERENT IMPLANT WAS USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH MINIMAL DELAY. PATIENT STATUS WAS GOOD. THIS REPORT IS FOR AN IMPLANT HOLDER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12576046 ↗