ORACLE 03.809.629Recalls & reported problems
Synthes GmbH · ORACLE TRIAL SPACER 9MM HEIGHT/8 DEG ANGLE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034725468), received between Mar 13, 2024 and Jan 27, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Activation, Positioning or Separation Problem2
- Material Integrity Problem2
Patient problems
- Foreign Body In Patient2
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 27, 2025Activation, Positioning or Separation Problem; Material Integrity Problem; Activation, Positioning or Separation Problem; Material Integrity Problem
ADDITIONAL INFORMATION RECEIVED STATES THAT THE BROKEN OFF PART OF THE INSTRUMENT HAD TO BE LEFT IN THE PATIENT. AN ATTEMPT WAS MADE TO REMOVE THE INSTRUMENT INTRAOPERATIVELY. NO ADDITIONAL INTERVENTIONS WERE MADE. THE SURGERY WAS NOT COMPLETED SUCCESSFULLY SINCE THE INSTRUMENT IS STUCK IN THE DISC SPACE, NO IMPLANT COULD BE INSERTED. THERE WAS A SURGICAL DELAY.
Patient problems: Foreign Body In Patient
MAUDE report 21240960 ↗MalfunctionMar 13, 2024Activation, Positioning or Separation Problem; Material Integrity Problem; Activation, Positioning or Separation Problem; Material Integrity Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: IT WAS REPORTED DURING SURGERY ON (B)(6) 2023 THE ORACLE TRIAL (9MM) BROKE IN THE PATIENT'S BODY DURING SURGERY. TRIAL CANNOT BE REMOVED WHICH CAUSED THE PROSTHESIS TO NOT BE IMPLANTED. PATIENT WAS CLOSED. THE PATIENT WAS CURRENTLY HOSPITALIZED FOR OBSERVATION. THIS REPORT IS FOR ONE ORACLE TRIAL SPACER 9MM HEIGHT/8 DEG ANGLE FOR (B)(4).
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 18896433 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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