X-PAC EI225508Recalls & reported problems
Expanding Innovations, Inc. · X-PAC Lateral Cage 22mm x 55mm x 4 - 8 degrees · 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 00850001720991), received between Sep 1, 2023 and Sep 1, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Collapse” (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
- Collapse1
Patient problems
- Intervertebral Disc Compression or Protrusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 1, 2023Collapse; Collapse
DURING IMPLANTATION, THE X-PAC LLIF CAGE WAS EXPANDED 2MM AS VERIFIED BY IMAGING AND THE SURGEON WAS SATISFIED WITH THE OUTCOME. THE FIRST FOLLOW UP VISIT WAS DURING (B)(6) 2023 AND THE PATIENT WAS DOING WELL AND REPORTED NO PAIN. HOWEVER, DURING A FOLLOW UP VISIT ON (B)(6) 2023, THE PATIENT REPORTED THAT PAIN HAD DEVELOPED. THE SURGEON REQUESTED AN IMAGE AND NOTED THAT THE IMPLANTED CAGE HAD REDUCED IN HEIGHT. THE SURGEON INDICATED THAT THE CAGE WOULD NEED TO BE REPLACED AND THE REVISION SURGERY WAS COMPLETED ON (B)(6) 2023.
Patient problems: Intervertebral Disc Compression or Protrusion
MAUDE report 17670600 ↗
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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