Vusion OS 551-7308ARecalls & reported problems
Ortho Development Corporation · 9 mm x 25 mm x 8 mm 3 Degree Lordotic · Class 2 · Implant
Data updated Oct 18, 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 00822409020942), received between Sep 17, 2020 and Sep 17, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2020Fracture; Fracture
WHILE ATTEMPTING TO INSERT AN INTERVERTEBRAL CAGE, THE FRAME OF THE CAGE TWISTED AND WAS DAMAGED AND BROKEN. A NEW CAGE WAS OPENED AND THE SAME THING OCCURRED. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED. THIS REPORT IS BEING FILED DUE TO THE POSSIBILITY THAT SOME SMALL PIECE(S) MAY HAVE REMAINED IN THE BODY.
Patient problems: Pain
MAUDE report 10547465 ↗
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
- Catalyft PL Expandable Interbody System 6069096Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall25 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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