SynCage 08.825.111SRecalls & reported problems
Synthes GmbH · SYNCAGE EVOLUTION SPACER-SMALL 10.5MM HEIGHT/10DEG-STERILE · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034760155), received between Nov 3, 2022 and Nov 3, 2022 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 3, 2022Material Integrity Problem; Material Integrity Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SOUTH KOREA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE CAGE WAS BROKEN DURING INSERTION. THE SURGERY WAS DELAYED BY 20 MINUTES IN RELATION TO THIS EVENT. THE FRAGMENTS OF THE BROKEN PRODUCT WERE EASILY REMOVED, AND THE SURGEON REPLACED THE PRODUCT WITH A NEW ONE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SYNCAGE EVOLUTION SPACER-SMALL 10.5MM HEIGHT/10DEG-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15722221 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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