SynCage 08.825.224SRecalls & reported problems
Synthes GmbH · SYNCAGE EVOLUTION SPACER-MED 15MM HEIGHT/14DEG-STERILE · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034760452), received between Feb 20, 2019 and Feb 20, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (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
- Migration1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 20, 2019Migration; Migration
IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A L5-S1 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SURGERY WITH SYNCAGE EVOLUTION AND BOWTI. THE SURGEON TOOK AT THE START OF STAGE 2 OF THE SURGERY (B)(6) 2019, AND NOTICED THAT THE BOWTI AND SYNCAGE BACKED OUT FROM ORIGINAL PLACEMENT ON DAY ONE OF SURGERY. SURGEON PERFORMED REVISION SURGERY LAST (B)(6) 2019. SYNCAGE AND BOWTI WERE REMOVED AND A SYNFIX EVOLUTION AND ANTEGRA PLATE WERE IMPLANTED. SURGERY WAS COMPLETED WITH NO COMPLICATIONS OR DELAYS. THIS REPORT IS FOR ONE (1) SYNCAGE EVOLUTION SPACER-MED 15MM HEIGHT/14DEG-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Code Available
MAUDE report 8354242 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
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- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
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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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