ModulusRecalls & reported problems across all models
Nuvasive, Inc. · 41 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 98
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls
- 0
We found 41 models of Modulus by Nuvasive, Inc. in the FDA's device registry (GUDID). Together they are named in 98 adverse event reports in the FDA's MAUDE database, received between Jun 17, 2019 and May 12, 2026 — classified as 23 injuries, 75 malfunctions.
The most frequently reported specific device problem is “Fracture” (42 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 Modulus problems
Device problems
- Fracture42
- Migration21
- Adverse Event Without Identified Device or Use Problem15
- Migration or Expulsion of Device11
- Unintended System Motion4
- Contamination2
- Detachment of Device or Device Component1
- Material Deformation1
Patient problems
- Foreign Body In Patient37
- No Clinical Signs, Symptoms or Conditions26
- Pain13
- Failure of Implant7
- Numbness4
- Bacterial Infection3
- Unspecified Infection3
- Bone Fracture(s)2
Modulus models
41 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Modulus 1775850Intervertebral fusion device with bone graft, thoracic37 reports
- Modulus 67940049P2Intervertebral fusion device with bone graft, cervical4 reports
- Modulus 1181855P2Intervertebral fusion device with bone graft, lumbar3 reports
- Modulus 1221245P2Intervertebral fusion device with bone graft, lumbar3 reports
- Modulus 67940002P2Intervertebral fusion device with bone graft, cervical3 reports
- Modulus 1921003P2Intervertebral fusion device with integrated fixation, lumbar2 reports
- Modulus 1921042P2Intervertebral fusion device with integrated fixation, lumbar2 reports
- Modulus 1921043P2Intervertebral fusion device with integrated fixation, lumbar2 reports
- Modulus 1921046P2Intervertebral fusion device with integrated fixation, lumbar2 reports
- Modulus 1181050P2Intervertebral fusion device with bone graft, thoracic2 reports
- Modulus 1181055P2Intervertebral fusion device with bone graft, thoracic2 reports
- Modulus 1221050P2Intervertebral fusion device with bone graft, lumbar2 reports
- Modulus 1225255P2Intervertebral fusion device with bone graft, thoracic2 reports
- Modulus 1091348P2Intervertebral fusion device with bone graft, lumbar2 reports
- Modulus 67940001P2Intervertebral fusion device with bone graft, cervical2 reports
- Modulus 67940037P2Intervertebral fusion device with bone graft, cervical2 reports
- Modulus 67940068P2Intervertebral fusion device with bone graft, cervical2 reports
- Modulus D1775850Intervertebral fusion device with integrated fixation, lumbar1 report
- Modulus D1300000ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Modulus D1300002ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Modulus D1300096ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Modulus 1305225Intervertebral fusion device with integrated fixation, lumbar1 report
- Modulus 1921050P2Intervertebral fusion device with integrated fixation, lumbar1 report
- Modulus 1181045P2Intervertebral fusion device with bone graft, thoracic1 report
- Modulus 1181245P2Intervertebral fusion device with bone graft, thoracic1 report
- Modulus 1181845P2Intervertebral fusion device with bone graft, lumbar1 report
- Modulus 1181850P2Intervertebral fusion device with bone graft, thoracic1 report
- Modulus 1221045P2Intervertebral fusion device with bone graft, lumbar1 report
- Modulus 1221250P2Intervertebral fusion device with bone graft, lumbar1 report
- Modulus 1225050P2Intervertebral fusion device with bone graft, lumbar1 report
- Modulus 1225055P2Intervertebral fusion device with bone graft, thoracic1 report
- Modulus 1225260P2Intervertebral fusion device with bone graft, thoracic1 report
- Modulus 1081308P2Intervertebral fusion device with bone graft, thoracic1 report
- Modulus 2080252P2Intervertebral fusion device with bone graft, lumbar1 report
- Modulus 2100308P2Intervertebral fusion device with bone graft, thoracic1 report
- Modulus 2104304P2Intervertebral fusion device with bone graft, lumbar1 report
- Modulus 6793001P2Intervertebral fusion device with bone graft, cervical1 report
- Modulus 6793037P2Intervertebral fusion device with bone graft, cervical1 report
- Modulus 67940003P2Intervertebral fusion device with bone graft, cervical1 report
- Modulus 67940036P2Intervertebral fusion device with bone graft, cervical1 report
- Modulus 67940000P2Intervertebral fusion device with bone graft, cervical1 report
Recent Modulus adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 12, 2026Unintended System Motion
IT WAS REPORTED THAT THE PATIENT WHO UNDERWENT ANTERIOR CERVICAL DECOMPRESSION AND FUSION SURGERY. THE CAGE WAS PLACED BETWEEN C4/5 VERTEBRAE IN THE PRIMARY SURGERY, THE FITTING WAS GOOD AND THE WOUND WAS CLOSED. HOWEVER, THE NEXT DAY THE CAGE HAD MOVED FORWARD, AND A CT SCAN TAKEN THE FOLLOWING WEEK SHOWED THAT IT HAD MOVED EVEN FURTHER FORWARD. SO, THE SURGEON REMOVED THE CAGE AND INSERTED NEW ONE WITH PLATE FOR FIXATION. WE DID NOT OBTAIN THE IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25151292 ↗MalfunctionApr 21, 2026Fracture
THE TIP OF INSERTER BROKE OFF IN IMPLANT AND TIP WAS NOT ABLE TO BE RETRIEVED. NO ADVERSE EFFECT TO PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 24944020 ↗MalfunctionApr 20, 2026Fracture
IT WAS REPORTED THAT THE TIP OF THE MODULUS XLIF INSERTER WAS SEVERED. THE TIP WAS BROKEN IN THE CAGE WHILE BEING INSERTED AND IT WAS LEFT SECURELY IN THE CAGE AND COULD NOT BE REMOVED. THE PATIENT IS DOING WELL, NO ADVERSE EFFECT.
Patient problems: Foreign Body In Patient
MAUDE report 24932307 ↗MalfunctionApr 16, 2026Fracture
IT WAS REPORTED THAT THE TIP OF THE INSERTER BROKE OFF IN THE CAGE WHILE BEING INSERTED DURING A XLIF CASE. THE TIP WAS LEFT IN THE PATIENT, AND THE CAGE WAS FURTHER ¿TAMPED¿ IN TO PLACE THE CAGE. THE FRACTURE TIP IS FULLY INSERTED AND STUCK INTO THE CAGE.
Patient problems: Foreign Body In Patient
MAUDE report 24903943 ↗MalfunctionApr 13, 2026Unintended System Motion
IT WAS REPORTED THAT ON (B)(6) 2022(?) THE PATIENT UNDERWENT SPINAL CAGE INSERTION USING THE XLIF METHOD BETWEEN THE THIRD AND FIFTH LUMBAR VERTEBRAE, FOLLOWED BY VERTEBRAL FUSION SURGERY BETWEEN THE THIRD AND FIFTH LUMBAR VERTEBRAE. THEN ON (B)(6) 2026 OUR SALES REPRESENTATIVE VISITED THE MEDICAL INSTITUTION FOR A POSTOPERATIVE FOLLOW-UP AND RECEIVED A REPORT THAT THE PATIENT HAD DEVELOPED NEUROLOGICAL SYMPTOMS. THE SURGEON SUGGESTED THAT THE SHIM MAY HAVE SHIFTED POSTERIORLY DURING TRACTION DEVICE PLACEMENT.
Patient problems: Unspecified Nervous System Problem
MAUDE report 24866326 ↗MalfunctionFeb 20, 2026Unintended System Motion
THE SURGEON USED 2 SPINAL CAGES FOR ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF). THE SURGEON REPORTED THAT THE CAGE HAD MOVED FORWARD 2 DAYS AFTER SURGERY, HE SHOULD PERFORM SURGERY AGAIN. THIS EVENT OCCURRED IN JAPAN. NO OTHER ADVERSE EFFECT REPORTED TO PATIENT.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 24405101 ↗MalfunctionFeb 20, 2026Unintended System Motion
IT WAS REPORTED THAT THE SURGEON USED 2 SPINAL CAGES FOR ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF). THE SURGEON INFORMED THAT THE CAGE MOVED FORWARD 2 DAYS AFTER SURGERY, HE SHOULD PERFORM SURGERY AGAIN. NO OTHER ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THIS EVENT OCCURRED IN JAPAN AND IS REPORTABLE TO PMDA.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 24404575 ↗MalfunctionFeb 12, 2026Fracture
IT WAS REPORTED THAT DURING INSERTION OF THE CAGE, THE TIP OF THE INSERTER BROKE OFF INSIDE IT. THE BROKEN PIECE IS IN THE CAGE, IMPLANTED IN THE PATIENT. THIS EVENT OCCURRED IN ITALY.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 24322669 ↗MalfunctionFeb 2, 2026Fracture
IT WAS REPORTED THAT WHILE INSERTING MODULUS IMPLANT, THE INNER THREADED PIECE OF THE INSERTER THAT INTERACTS WITH THE THREADED HOLE IN THE IMPLANT BROKE OFF AND STAYED IN IMPLANT. THEY COULD NOT GET THE IMPLANT OUT SINCE IT WAS MORE THAN HALFWAY IN AND SO WE JUST TAMPED IMPLANT FURTHER INTO DISC SPACE AND LEFT THE BROKEN PIECE IN THE IMPLANT. NOTHING WAS PUT OVER THE TIP; IT¿S THREADED ALL THE WAY INTO THE IMPLANT AND BROKE OFF. NO REVISION NECESSARY AND AS OF NOW NO REPORTED EFFECTS TO PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 24236466 ↗MalfunctionJan 13, 2026Migration
IT WAS REPORTED THAT A PATIENT WITH CERVICAL SPONDYLOSIS UNDERWENT SPINAL CAGE INSERTION SURGERY BETWEEN THE C4/C6 VERTEBRAL ON (B)(6) 2025. IT WAS CONFIRMED THAT THE CAGE INSERTED INTO THE C4/C5 VERTEBRAL HAD SHIFTED APPROXIMATELY 1-2 MM. THE PATIENT FELT DIFFICULTY SWALLOWING AND REQUESTED RESURGERY ALTHOUGH THE SURGEON CONSIDERED THE CASE DID NOT NEED SURGERY. WE DID NOT OBTAIN THE IMPLANT. WE DO NOT RECEIVE ANY OTHER ADVERSE PATIENT CONSEQUENCES REPORTED.
Patient problems: Dysphagia/ Odynophagia
MAUDE report 24057321 ↗InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem
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
Patient problems: Unspecified Kidney or Urinary Problem
MAUDE report 24038924 ↗InjuryJan 7, 2026Migration or Expulsion of Device
IT WAS REPORTED THAT THE PATIENT UNDERWENT L2/L5 LATERAL LUMBAR INTERBODY FUSION AND INSERTED CAGES FOR EACH INTERVERTEBRAL SPACES. AFTER CONFIRMING THE POSITION OF THE L4/5 CAGE WITH A C-ARM, THE SURGEON ATTEMPTED TO ADJUST ITS PLACEMENT. HOWEVER, IT WAS DIFFICULT TO GRASP THE CAGE WITH THE INSERTER. THE SURGEON TRIED TO REMOVE THE CAGE USING INSTRUMENTS E.G. FORCEPS BUT THE CAGE WAS PUSHED FURTHER TOWARD THE OPPOSITE SIDE. ULTIMATELY, THE CAGE WAS DISLODGED FROM THE INTERVERTEBRAL SPACE AND MIGRATED TO THE VENTRAL ASPECT OF THE L5/SACRUM. DUE TO THE PATIENT'S POSTURE DURING THE SURGERY, THE DISLODGED IMPLANT COULD NOT BE REMOVED. THE SURGEON DECIDED TO LEAVE THE CAGE IN-SITU AS THERE WAS A LOW RISK OF DAMAGING THE SURROUNDING VESSELS BECAUSE OF NO SPIKE ON THE CAGE SURFACE. AND NEW SPINAL CAGE WAS INSERTED INTO L4/5, AND THE SURGERY WAS COMPLETED. THE SURGEON COMMENTED THAT THE PATIENT'S L5 VERTEBRA WAS IRREGULARLY SHAPED, WHICH INTERFERED WITH THE SURGICAL INSTRUMENTS AND MADE GRASPING THE CAGE DIFFICULT. THE DROPPED CAGE WAS REMOVED BY LAPAROSCOPIC SURGERY ON (B)(6) 2025. WE DO NOT RECEIVE ANY OTHER ADVERSE PATIENT CONSEQUENCES REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 23988704 ↗MalfunctionSep 25, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF A MODULUS XLW BROKE OFF INSIDE THE CAGE AND COULD NOT BE RETRIEVED.
Patient problems: Foreign Body In Patient
MAUDE report 23146547 ↗MalfunctionSep 10, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF A MODULUS XLW INSERTER BROKE OFF INSIDE THE IMPLANTED CAGE AND WAS UNABLE TO BE RETRIEVED.
Patient problems: Foreign Body In Patient
MAUDE report 23016045 ↗MalfunctionMay 9, 2025Migration or Expulsion of Device; Migration or Expulsion of Device
THE PATIENT HAS PRIMARY SURGERY TO INSERT MODULUS CERVICAL CAGE INTO C6/C7 ON (B)(6) 2025 BECAUSE OF KYPHOSIS, CERVICAL HERNIA. AFTER THE SURGERY, THE CAGE BACKED OUT ABOUT HALFWAY FROM THE INTERVERTEBRAL SPACE. ON (B)(6) 2025 THE SURGEON REINSERTED THE CAGE AND FIXED THE VERTEBRAL BODY WITH A PLATE FROM ANOTHER MANUFACTURER. THE SURGEON SAID THAT THE PATIENT HAD A KYPHOSIS, AND THE WEIGHT ON THE FRONT OF THE VERTEBRAL BODY WAS TOO STRONG, WHICH MAY HAVE CAUSED THE CAGE TO BACK OUT. HE THINKS IT MAY HAVE BEEN BETTER TO HAVE PLACED IT A LITTLE FURTHER BACK FROM THE BEGINNING. AND THERE WAS NO EXTERNAL FIXATION AFTER THE SURGERY, SO THAT MAY HAVE BEEN THE CAUSE, AND HE THOUGHT THAT THERE WAS NO PROBLEM WITH THE CAGE. WE DO NOT RECEIVE ANY OTHER ADVERSE PATIENT CONSEQUENCES REPORTED.
Patient problems: Failure of Implant
MAUDE report 21994027 ↗
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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