inViZia® 07.01616.005Recalls & reported problems
Zimmer Spine, Inc. · Class 2
Data updated Oct 18, 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 00889024325746), received between Feb 9, 2021 and Feb 9, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Unstable” (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 18, 2026.
Most reported problems
Device problems
- Unstable1
Patient problems
- Inadequate Osseointegration1
- 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.
InjuryFeb 9, 2021Unstable; Unstable
IT WAS REPORTED THAT A SCREW FRACTURED AND BACKED OUT POST-OP, WHICH CAUSED THE CONSTRUCT TO BE UNSTABLE AND FUSION WAS NOT ACHIEVED. ADDITIONALLY, THE CAGE WAS FOUND TO BE CRACKED. A 2-LEVEL PLATE, 6 SCREWS, AND CAGE WERE REMOVED DURING A REVISION SURGERY. THIS IS REPORT SEVEN OF EIGHT FOR THIS EVENT.
Patient problems: Inadequate Osseointegration; No Code Available; Pain
MAUDE report 11302499 ↗
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- Elegance® Anterior Cervical Plate 53430344Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- ATLANTIS® Anterior Cervical Plate System 876-170Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- XLP 7565060Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430113Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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