Vusion OS 551-7309ARecalls & reported problems
Ortho Development Corporation · 9 mm x 25 mm x 9 mm 3 Degree Lordotic · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00822409020959), received between Dec 22, 2025 and Jan 19, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
- Material Integrity Problem1
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 19, 2026Material Integrity Problem
AN INTERVERTEBRAL CAGE WAS BEING INSERTED AND WAS DAMAGED. ATTEMPTS WERE MADE TO RETRIEVE THE FRAGMENTS. THE REAR SECTION OF THE CAGE WAS RECOVERED BUT THE FRONT SECTION WAS UNRECOVERABLE AND WAS LEFT IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 24109074 ↗InjuryDec 22, 2025Break; Break
AN INTERVERTEBRAL CAGE WAS BEING INSERTED AND WAS DAMAGED. ATTEMPTS WERE MADE TO RETRIEVE THE FRAGMENTS, BUT DUE TO THEIR PARTIAL LODGING WITHIN THE VERTEBRAL SPACE, ONE PIECE COULD NOT BE RECOVERED AND WAS LEFT IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 23873810 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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