Modulus 67940001P2Recalls & reported problems
Nuvasive, Inc. · Modulus Cervical, 6x15x12mm 7° · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517958983), received between Aug 27, 2024 and Jan 13, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Migration” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Migration1
Patient problems
- Dysphagia/ Odynophagia1
- Muscle Weakness/Atrophy1
- Neck Pain1
- Stenosis1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS EVENT WAS IDENTIFIED DURING A REVIEW OF THE CERVICAL INTERBODY PMCF STUDY THAT NOTED A PATIENT UNDERWENT A ANTERIOR CERVICAL DISCECTOMY FUSION (ACDF) PROCEDURE ON (B)(6) 2021 AT C5-T1. ON (B)(6) 2024 THE PATIENT WAS SUFFERING FROM LEFT TRICEP, BICEP, AND SHOULDER WEAKNESS AND MRI AND EMG REVEALED C6-C7 FORAMINAL STENOSIS. ON (B)(6) 2024 THE PATIENT UNDERWENT A LEFT C6-C7 FORAMINOTOMY WITH NO ADDITIONAL PROBLEMS REPORTED.
Patient problems: Muscle Weakness/Atrophy; Neck Pain; Stenosis
MAUDE report 20080869 ↗
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- EIT CIF cage CUI8060LEIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Cervical1 recall1 report
- CONSTRUX - MINI Ti 37-7206SPOrthofix US LLC · Intervertebral fusion device with bone graft, cervical1 recall0 reports
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- CONSTRUX - MINI PTC 37-4211SPOrthofix US LLC · Intervertebral fusion device with bone graft, cervical1 recall0 reports
- CONSTRUX - MINI PTC 37-5211SPOrthofix US LLC · Intervertebral fusion device with bone graft, cervical1 recall0 reports
- CONSTRUX - MINI Ti 37-8105SPOrthofix US LLC · Intervertebral fusion device with bone graft, cervical1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.