SynCage 08.825.323SRecalls & reported problems
Synthes GmbH · SYNCAGE EVOLUTION SPACER-LARGE 13.5MM 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 10705034760667), received between Dec 11, 2019 and Dec 11, 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
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 11, 2019Migration; Migration
IT WAS REPORTED THAT ON (B)(6) 2019, HARDWARE REMOVAL OF THE SYNCAGE EVOLUTION IMPLANT WAS PERFORMED DUE TO POST-OP MIGRATION AND PAIN DURING ANTERIOR SPINAL FUSION. THE ORIGINAL IMPLANTATION DATE WAS ON (B)(6) 2019. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. AS THE CAGE SPIT ANTERIORLY THE PATIENT'S ANATOMY TILTED OFF TO THE SIDE. ALL SCREWS ARE INTACT AND STILL IN ORIGINAL POSITION. THE PROCEDURE OUTCOME WAS UNKNOWN. PATIENT OUTCOME CONSEQUENCES PATIENT EXPERIENCED POST-OP PAIN REQUIRING SECONDARY SURGERY. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS, (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY# 3). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: No Code Available; Pain
MAUDE report 9455737 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
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- EIT TLIF Inserter TFT30101EIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Lumbar88 reports
- 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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