CoRoentRecalls & reported problems across all models
Nuvasive, Inc. · 64 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 102
- Deaths reported
- 2
- Injuries reported
- 28
- Recalls
- 0
We found 64 models of CoRoent by Nuvasive, Inc. in the FDA's device registry (GUDID). Together they are named in 102 adverse event reports in the FDA's MAUDE database, received between Jan 5, 2016 and Feb 9, 2026 — classified as 2 deaths, 28 injuries, 72 malfunctions.
The most frequently reported specific device problem is “Fracture” (49 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported CoRoent problems
Device problems
- Fracture49
- Adverse Event Without Identified Device or Use Problem24
- Break9
- Migration or Expulsion of Device9
- Migration7
- Malposition of Device3
- Detachment of Device or Device Component2
- Failure to Osseointegrate2
Patient problems
- No Clinical Signs, Symptoms or Conditions38
- Pain14
- Failure of Implant11
- Foreign Body In Patient7
- Patient Problem/Medical Problem5
- Damage to Ligament(s)4
- Hematoma4
- Bone Fracture(s)3
CoRoent models
64 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CoRoent 6791714Intervertebral fusion device with bone graft, cervical9 reports
- CoRoent 6790225Intervertebral fusion device with bone graft, cervical6 reports
- CoRoent 6980845Intervertebral fusion device with bone graft, lumbar1 death5 reports
- CoRoent 6921055Intervertebral fusion device with bone graft, lumbar4 reports
- CoRoent 6980850Intervertebral fusion device with bone graft, lumbar3 reports
- CoRoent 6770710CP2Intervertebral fusion device with integrated fixation, cervical3 reports
- CoRoent 7151050Intervertebral fusion device with bone graft, lumbar2 reports
- CoRoent 7151055Intervertebral fusion device with bone graft, lumbar2 reports
- CoRoent 7151260Intervertebral fusion device with bone graft, lumbar2 reports
- CoRoent 5485540Intervertebral fusion device with bone graft, cervical2 reports
- CoRoent 6790153ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- CoRoent 6791715Intervertebral fusion device with bone graft, cervical2 reports
- CoRoent 6900930ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- CoRoent 6908855Intervertebral fusion device with bone graft, lumbar2 reports
- CoRoent 6980855Intervertebral fusion device with bone graft, lumbar2 reports
- CoRoent 6050823P2Intervertebral fusion device with bone graft, lumbar2 reports
- CoRoent 5181308P2Intervertebral fusion device with bone graft, lumbar2 reports
- CoRoent 6130923P2Intervertebral fusion device with bone graft, thoracic2 reports
- CoRoent 1903013Intervertebral fusion device with integrated fixation, cervical2 reports
- CoRoent 1903014Intervertebral fusion device with integrated fixation, cervical2 reports
- CoRoent 6006806Intervertebral fusion device with bone graft, lumbar1 report
- CoRoent 6006807Intervertebral fusion device with bone graft, lumbar1 report
- CoRoent 6020001Intervertebral fusion device with bone graft, lumbar1 report
- CoRoent 6020003ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- CoRoent 6040828Intervertebral fusion device with bone graft, lumbar1 report
- CoRoent 6080823Intervertebral fusion device with bone graft, lumbar1 report
- CoRoent 6080828Intervertebral fusion device with bone graft, lumbar1 report
- CoRoent 6081223Intervertebral fusion device with bone graft, lumbar1 report
- CoRoent 6081228Intervertebral fusion device with bone graft, lumbar1 report
- CoRoent 6111055Intervertebral fusion device with bone graft, lumbar1 report
- CoRoent 6121023Intervertebral fusion device with bone graft, lumbar1 report
- CoRoent 6171060Intervertebral fusion device with bone graft, cervical1 report
- CoRoent 6180015ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- CoRoent 6200450Intervertebral fusion device with bone graft, cervical1 report
- CoRoent 6308850Intervertebral fusion device with bone graft, lumbar1 report
- CoRoent 6421050SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- CoRoent 6790114ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- CoRoent 6790226Intervertebral fusion device with bone graft, cervical1 report
- CoRoent 6791712Intervertebral fusion device with bone graft, cervical1 report
- CoRoent 6791716Intervertebral fusion device with bone graft, cervical1 report
- CoRoent 6910250Intervertebral fusion device with bone graft, lumbar1 report
- CoRoent 6914260Intervertebral fusion device with bone graft, lumbar1 report
- CoRoent 6921060Intervertebral fusion device with bone graft, lumbar1 report
- CoRoent 6921250Intervertebral fusion device with bone graft, lumbar1 report
- CoRoent 6981045Intervertebral fusion device with bone graft, lumbar1 report
- CoRoent 6990635Intervertebral fusion device with bone graft, lumbar1 report
- CoRoent 6990640Intervertebral fusion device with bone graft, lumbar1 report
- CoRoent D1658087Intervertebral fusion device with bone graft, lumbar1 report
- CoRoent 6130823Intervertebral fusion device with bone graft, lumbar1 report
- CoRoent 5384254Intervertebral fusion device with bone graft, lumbar1 report
- CoRoent 5214402Intervertebral fusion device with bone graft, lumbar1 report
- CoRoent 5294402SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- CoRoent 6080823P2Intervertebral fusion device with bone graft, lumbar1 death1 report
- CoRoent 7151060P2Intervertebral fusion device with bone graft, lumbar1 report
- CoRoent 6130823P2Intervertebral fusion device with bone graft, thoracic1 report
- CoRoent 6770810CP2Intervertebral fusion device with integrated fixation, cervical1 report
- CoRoent 6770815CP2Intervertebral fusion device with integrated fixation, cervical1 report
- CoRoent 5181304P2Intervertebral fusion device with bone graft, lumbar1 report
- CoRoent 5191304P2Intervertebral fusion device with bone graft, thoracic1 report
- CoRoent 5271300P2Intervertebral fusion device with bone graft, lumbar1 report
- CoRoent 5271308P2Intervertebral fusion device with bone graft, thoracic1 report
- CoRoent 5281348P2Intervertebral fusion device with bone graft, thoracic1 report
- CoRoent 1903016Intervertebral fusion device with integrated fixation, cervical1 report
- CoRoent 6920860P2Intervertebral fusion device with bone graft, thoracic1 report
Recent CoRoent adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionDec 16, 2025Fracture; Fracture
IT WAS REPORTED THAT THE COROENT PEEK CAGE BROKE UP INTO SMALLER PIECES DURING IMPACTION. THE SURGEON USED THE CORRECT TECHNIQUE AND WAS USED IN TANDEM WITH XLIF SLIDES TO PREVENT STRESS ON THE CAGE. FRAGMENTS OF CAGE WERE LEFT INSIDE OF PATIENT DURING XLIF SURGERY AND WERE UNABLE TO RETRIEVED. THIS EVENT OCCURRED IN SINGAPORE.
Patient problems: Foreign Body In Patient
MAUDE report 23819097 ↗MalfunctionNov 17, 2025Fracture; Fracture
THE ITEM BROKE DURING SURGERY. NO PART OF THE INSTRUMENT REMAINED INSIDE THE PATIENT. THIS EVENT OCCURRED IN SPAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23575906 ↗MalfunctionSep 15, 2025Fracture; Fracture
COROENT PEEK CAGE FRACTURED AND WAS REPLACED DURING SURGERY. THIS EVENT OCCURRED IN NEW ZEALAND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23053304 ↗MalfunctionMar 25, 2025Fracture; Fracture
DURING A PROCEDURE, THE DISTAL ARTICULATING TIP OF THE PITUITARY RONGEUR FRACTURED OFF. THE PIECE WAS RETRIEVED AND WAS NOT RETAINED IN THE PATIENT. NO FURTHER PATIENT OR PROCEDURE IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21692039 ↗MalfunctionDec 9, 2024Break; Fracture; Break; Fracture
IT WAS REPORTED THAT DURING A SPINAL PROCEDURE AN INTERVERTEBRAL SPACER BROKE NEAR THE INSERTER CONNECTION WHEN IT WAS BEING IMPLANTED INTO THE PATIENT. THE BROKEN DEVICE WAS ABLE TO BE RETRIEVED. IT WAS REPORTED THAT THE PROCEDURE TIME WAS EXTENDED TO REMOVE THE BROKEN DEVICE. NO PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20887966 ↗MalfunctionDec 9, 2024Break; Fracture; Break; Fracture
NEW OR UPDATED INFORMATION LISTED ON H10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20887129 ↗MalfunctionOct 22, 2024Fracture; Fracture
DURING A LUMBAR PROCEDURE WHEN INSERTING THE INTERBODY SPACER INTO THE DISC SPACE, THE DEVICE FRACTURED. A SECOND DEVICE WAS USED AND THE CASE WAS ABLE TO BE COMPLETED NO IMPACT TO THE PATIENT OR CASE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20510099 ↗MalfunctionSep 19, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE, THE TRIAL INSERTER TIP FRACTURED OFF INSIDE THE TRIAL. THE FRACTURED PORTION WAS RETRIEVED ALONG WITH THE TRIAL AND NO FRAGMENT WAS LEFT IN-SITU. THERE WAS NO REPORTED IMPACT TO THE PATIENT, USER, OR PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20262183 ↗MalfunctionSep 10, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE, THE TRIAL INSERTER TIP FRACTURED OFF INSIDE THE TRIAL. THE FRACTURED PORTION WAS RETRIEVED ALONG WITH THE TRIAL AND NO FRAGMENT WAS LEFT IN-SITU. THERE WAS NO REPORTED IMPACT TO THE PATIENT, USER, OR PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20186164 ↗MalfunctionJul 19, 2024Fracture; Fracture
ON (B)(6) 2024 A PATIENT UNDERWENT A LATERAL INTERBODY FUSION PROCEDURE ON UNKNOWN LEVELS OF THE SPINE. DURING INSERTION OF THE VERTEBRAL SPACER IT FRACTURED. THE FRACTURED PORTIONS WERE RETRIEVED FROM THE PATIENT AND THE REMAINDER OF THE IMPLANT REMAINS IN SITU. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19784421 ↗MalfunctionJul 12, 2024Break; Break
IT WAS REPORTED THAT DURING A LUMBAR SPINAL SURGERY AN INTERVERTEBRAL SPACER BROKE WHILE BEING PLACED IN THE PATIENT. THE BROKEN IMPLANT WAS UNABLE TO BE REMOVED AND WAS RETAINED IN-SITU. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19733535 ↗InjuryMay 2, 2024Migration or Expulsion of Device; Migration or Expulsion of Device
ON (B)(6) 2024 A PATIENT UNDERWENT LATERAL INTERBODY FUSION PROCEDURE ON UNCONFIRMED OF THE LUMBAR SPINE. THE SURGERY WAS COMPLETED WITHOUT ISSUE. ON A UNKNOWN DATE FOLLOWING THE PROCEDURE THE PATIENT WAS EXPERIENCING DIFFICULTY WALKING DURING EXAMINATION AND IMAGING DISCOVERED THE VERTEBRAL SPACER AT THE L4/L5 LEVEL HAD MIGRATED. ON (B)(6) 2024 A REVISION OCCURRED WHERE THE MIGRATED CAGE WAS REPLACED. THE REVISION SURGERY WAS COMPLETED WITH NO ISSUE OR ADVERSE CONSEQUENCES TO THE PATIENT. MULTIPLE RADIOGRAPHS WERE PROVIDED FOR REVIEW FROM POST THE INDEX PROCEDURE AND PRE REVISION PROCEDURE. THESE RADIOGRAPHS WERE REVIEWED BY NUVASIVE'S DIRECTOR OF MEDICAL AFFAIRS AND HE OBSERVED WHAT APPEARED TO BE A COMPRESSION FRACTURE OF THE L4 VERTEBRAL BODY INVOLVING THE SUPERIOR ENDPLATE. IN ADDITION TO THE MIGRATED VERTEBRAL SPACER THAT WAS REPORTED AT THE L4/L5 LEVEL IT WAS ALSO OBSERVED THE SPACER AT L3/L4 HAD EXPERIENCED MIGRATED INTO THE DISC SPACE AND SUBSIDED. 2 OF 2
Patient problems: Ambulation or Postural Difficulties; Vertebral Fracture
MAUDE report 19233557 ↗MalfunctionMay 2, 2024Migration or Expulsion of Device; Migration or Expulsion of Device
ON (B)(6) 2024 A PATIENT UNDERWENT LATERAL INTERBODY FUSION PROCEDURE ON UNCONFIRMED OF THE LUMBAR SPINE. THE SURGERY WAS COMPLETED WITHOUT ISSUE. ON A UNKNOWN DATE FOLLOWING THE PROCEDURE THE PATIENT WAS EXPERIENCING DIFFICULTY WALKING DURING EXAMINATION AND IMAGING DISCOVERED THE VERTEBRAL SPACER AT THE L4/L5 LEVEL HAD MIGRATED. ON (B)(6) 2024 A REVISION OCCURRED WHERE THE MIGRATED CAGE WAS REPLACED. THE REVISION SURGERY WAS COMPLETED WITH NO ISSUE OR ADVERSE CONSEQUENCES TO THE PATIENT. 1 OF 2.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 19233380 ↗InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TWO (2) LEVEL EXTREME LATERAL INTERBODY FUSION PROCEDURE FROM L3 TO L5 WITH PERCUTANEOUS POSTERIOR FIXATION. SUBSEQUENTLY, APPROXIMATELY SIX (6) WEEKS LATER, IT WAS NOTED THAT THE PATIENT HAD SUFFERED POSTOPERATIVE COMPLICATIONS THAT REQUIRED SEQUENTIAL RE-OPERATIONS INCLUDING A STAPHYLOCOCCUS INFECTION, PAIN, AND CANAL COMPRESSION. INFORMATION REGARDING THE DATE(S), QUANTITY, AND NATURE OF THE RE-OPERATIONS WAS NOT PROVIDED; HOWEVER, IT WAS NOTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE TO REMOVE THE L3/L4 INTERBODY VIA AN ANTERIOR APPROACH AND REPLACE WITH AN ANTERIOR LUMBAR INTERBODY FUSION WITH INTERFIXATION. FOLLOWING THE REVISION, IT WAS NOTED THAT THE PATIENT HAD ABDOMINAL BLEEDING AND WAS TRANSFERRED TO ANOTHER HOSPITAL FOR TREATMENT. ADDITIONAL INFORMATION REPORTED THE PATIENT'S CONDITION HAS IMPROVED. THE SURGEON DOES NOT BELIEVE THE COMPLICATIONS WERE RELATED TO THE PRODUCTS USED. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Bacterial Infection; Pain
MAUDE report 18927274 ↗
Other Nuvasive, Inc. products
All Nuvasive, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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