Zavation 360-H092700Recalls & reported problems
Zavation LLC · eZspand PLIF/T-PLIF 9x27x0°, 10.5-15mm · 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 00842166126480), received between Apr 21, 2025 and Apr 21, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Patient Device Interaction 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.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Inadequate Osseointegration1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 21, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
ORIGINAL SURGERY WAS (B)(6) 2025. SURGEON REVIEWED 3 MONTHS POST OP IMAGES AND NOTICED THAT THE CAGE IS HAS BACKED OUT OF THE DISC SPACE 1CM APPROXIMATELY. CAGE DOES NOT LOOK COLLAPSED IN IMAGE. PATIENT HAD SUBSEQUENT RADICULAR LEG PAIN DUE TO CAGE POSITION. THE PATIENT REQUIRED EXPLANT SURGERY TO REMOVE CAGE. SURGERY TOOK PLACE ON (B)(6) 2025. SURGEON IS MONITORING 2 OTHER PATIENTS WHERE CAGES LOOK TO BE POSTERIOR BACKING OUT OF DISK SPACE BUT NOT COLLAPSED. BOTH PATIENTS ARE ASSYMPTOMATIC.
Patient problems: Inadequate Osseointegration
MAUDE report 21877724 ↗
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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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