CoRoent D1658087Recalls & reported problems
Nuvasive, Inc. · Oblique TLIF Inserter, 10x25mm Impact QC · Class 2
All models of CoRoent (64)
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 00887517415967), received between Nov 18, 2021 and Nov 18, 2021 — classified as 1 malfunction.
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
- No Apparent Adverse Event1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 18, 2021No Apparent Adverse Event; No Apparent Adverse Event
ON (B)(6) 2021 A PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION PROCEDURE FROM L4 TO L5. DURING THE PROCEDURE AN INSTRUMENT FRACTURED IN THE PATIENT WHILE PERFORMING A ROTATIONAL MANEUVER. THE FRACTURED PORTION OF THE DEVICE WAS LEFT IN THE PATIENT AND RADIOGRAPHS CONFIRMED THAT IT WAS TOTALLY WITHIN THE VERTEBRAL BODY. THERE IS NO PLANS FOR REVISION AS THE PATIENT IS ASYMPTOMATIC.
Patient problems: Foreign Body In Patient
MAUDE report 12838087 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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