Modulus 1181050P2Recalls & reported problems

Nuvasive, Inc. · Modulus XL, 10x18x50mm 10° · Class 2 · Implant

All models of Modulus (41)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 00887517725882), received between Apr 11, 2024 and Jan 7, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Migration1
Migration or Expulsion of Device1

Patient problems

Foreign Body In Patient1
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

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 ↗
MalfunctionApr 11, 2024Migration; Migration
ON (B)(6) 2024 AN EXTREME LATERAL INTERBODY FUSION WAS PERFORMED AT L3/4. ON (B)(6) 2024 IT WAS DISCOVERED THE INTERBODY BACKED OUT. NO PATIENT INJURY WAS REPORTED. NO REVISION SURGERY IS PLANNED. THE PATIENT IS UNDER OBSERVATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19092494 ↗

Device details

UDI-DI	`00887517725882`
Brand	Modulus
Model	1181050P2
Company	Nuvasive, Inc.
Product code	PHM · Intervertebral fusion device with bone graft, thoracic
Class	Class 2
FDA submission	K163230
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 14, 2025

Device type (GMDN): Metallic spinal interbody fusion cage

A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be packaged with the cage.

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All Intervertebral fusion device with bone graft, thoracic devices →

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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