NA 03.809.900Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034726540), received between Sep 23, 2019 and Sep 23, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Component Missing” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2019Component Missing; Component Missing

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN ARGENTINA AS FOLLOWS: DURING A CAGE ORACLE LUMBAR SURGERY LATERAL, IT WAS DISCOVERED THAT THE PRODUCT IS MISSING A SCREW, WHICH DOES NOT ALLOW THE VALVES TO BE PLACED IN THE RETRACTOR. THE SEPARATOR COULD NOT BE USED AT THE TIME OF SURGERY AND THEREFORE THE IMPLANT COULD NOT BE PLACED, THE RETRACTOR WAS FUNDAMENTAL FOR ITS PLACEMENT. IT WAS DECIDED NOT TO MAKE THE IMPLANT PLACEMENT, THEREFORE, THERE WILL BE NO REPROGRAM DATE SCHEDULED. THIS COMPLAINT INVOLVES ONE (1) ORACLE RETRACTOR HANDLE.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9106408 ↗