Modulus 1921043P2Recalls & reported problems
Nuvasive, Inc. · Modulus ALIF, 10x38x28mm 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517020161), received between Aug 27, 2024 and Aug 28, 2024 — classified as 2 injuries.
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
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Pain2
- Paresthesia1
- Vertebral Fracture1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 28, 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 PMCF LUMBAR INTERBODY STUDY THAT NOTED A PATIENT UNDERWENT A ANTERIOR LUMBAR INTERBODY FUSION ON (B)(6) 2024. ON (B)(6) 2024 PATIENT COMPLAINED OF WORSENING LOW BACK AND RIGHT LEG PAIN IN REHAB AND A HORIZONTAL FRACTURE OF THE L5 VERTEBRA WAS SEEN ON THE SUBSEQUENT CT AND MRI WITH NO NEW NEURAL COMPRESSION. ALL OTHER HARDWARE WAS NOTED AS BEING INTACT. ON (B)(6) 2024 A REVISION TOOK PLACE FOR A FUSION FROM L2-PELVIS. SHE TOLERATED THE PROCEDURE WELL AND NOTED IMPROVEMENT OF PAIN.
Patient problems: Pain; Vertebral Fracture
MAUDE report 20087001 ↗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 PMCF LUMBAR INTERBODY STUDY THAT NOTED A PATIENT UNDERWENT A ANTERIOR LUMBAR INTERBODY FUSION ON (B)(6) 2023 AT L4/5. ON (B)(6) 2024 THE PATIENT REPORTED RADICULAR PAIN AND A REVISION TOOK PLACE WHERE A LAMINECTOMY WAS PERFORMED A L4/5. ON (B)(6) 2024 PATIENT REPORTS HER RADICULAR PAIN WAS RESOLVED HOWEVER, SHE NOW HAS "PINS AND NEEDLES" SENSATION IN HER LEFT LEG. MONITORING WILL CONTINUE.
Patient problems: Pain; Paresthesia
MAUDE report 20082123 ↗
Other Intervertebral fusion device with integrated fixation, lumbar devices
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- IdentiTi 232-10-85-250Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall5 reports
- IdentiTi 132-10-85-300Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall3 reports
- IdentiTi 232-10-85-350Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall2 reports
- MectaLIF Anterior 03.30.301Medacta International SA · Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall2 reports
- IdentiTi 232-11-90-350Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall1 report
- MectaLIF Anterior 03.30.300Medacta International SA · Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall1 report
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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