CoRoent 5384254Recalls & reported problems
Nuvasive, Inc. · Oblique TLIF, 8x14x25mm 4° · Class 2 · Implant
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 00887517620620), received between Jun 20, 2017 and Jun 20, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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
- Migration or Expulsion of Device1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 20, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
ON (B)(6) 2016, A PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4-L5 DISC SPACE, DURING INSERTION THE INSERTER TANG BROKE OFF AND WAS NOT RETRIEVED. NO PATIENT INJURY REPORTED. DURING A LATER FOLLOW UP VISIT RADIOGRAPHS SHOWED THE INTERBODY SPACER HAD MIGRATED. ON (B)(6) 2017 A REVISION PROCEDURE TOOK PLACE WHERE THE MIGRATED SPACER WAS REPLACED HOWEVER THE PREVIOUSLY UN-RETRIEVED INSERTER FRAGMENT WAS AGAIN LEFT IN-SITU. NO PATIENT INJURY REPORTED.
Patient problems: Failure of Implant
MAUDE report 6654290 ↗
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
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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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