CoRoent 6770710CP2Recalls & reported problems
Nuvasive, Inc. · Interlock II Ti-C, 7x17x14mm 10° · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517812414), received between May 27, 2022 and Feb 9, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Break1
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 9, 2026Break; Crack
IT WAS REPORTED THAT THE CAGE WAS ATTACHED PROPERLY TO INSERTER BY SCRUB TECH. THE SURGEON LIGHTLY MALLETS THE INSERTER TO IMPLANT INTO PATIENT. AS HE STRIKES THE INSERTER THE CAGE CRACKS IN 2 DIFFERENT PLACES. THE THIN SUPPORTS BETWEEN EACH SCREW HOLE ON THE ANTERIOR SIDE CRACKED DEEPLY INTO THE PEEK AND THE IMPLANT NEEDED TO BE EXPLANTED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24296467 ↗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 1 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17455964 ↗MalfunctionMay 27, 2022Fracture; Fracture
INITIALLY, IT WAS REPORTED THE CAGE CRACKED INTRAOPERATIVELY WHILE IMPACTING INTO THE DISC SPACE. THERE WAS NO PATIENT INJURY OR ADVERSE IMPACT. UPON EVALUATION BY THE MANUFACTURER OF THE RETURNED CAGE, IT WAS FOUND PORTIONS OF THE CAGE WERE FRACTURED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14522471 ↗
Other Intervertebral fusion device with integrated fixation, cervical devices
- NA 03.617.902Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical103 reports
- NA 03.617.900Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical77 reports
- Divergence® Anterior Cervical Fusion System G6626525Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical75 reports
- Divergence® Anterior Cervical Fusion System G6626526Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical49 reports
- NA 03.617.905Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical29 reports
- NA 03.617.904Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical27 reports
- Divergence® Anterior Cervical Fusion System G6626746Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical21 reports
- NA 03.647.972Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical17 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page