CoRoent 6770810CP2Recalls & reported problems
Nuvasive, Inc. · Interlock II Ti-C, 8x17x14mm 10° · 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 00887517812445), received between Aug 3, 2023 and Aug 3, 2023 — 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 16, 2026.
Most reported problems
Device problems
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 3, 2023Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL INTERBODY FUSION PROCEDURE USING TWO (2) INTERLOCK II INTERBODIES. DURING THE PROCEDURE, IT WAS NOTED THAT BOTH INTERBODIES FRACTURED UPON INSERTION OF THE FIXATION SCREWS. THE 7MM INTERBODY FRACTURED AT THE THIN POINT DIRECTLY ABOVE THE CENTER SCREW. THE 7MM CAGE WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH A NEW IMPLANT. ADDITIONALLY, THE 8MM CAGE FRACTURED ABOVE THE SCREW, TO THE LEFT OF THE DIRECTIONAL ARROW ON THE IMPLANT. THE 8MM CAGE WAS RETAINED. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. REPORT 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17455972 ↗
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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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