Modulus 1921003P2Recalls & reported problems
Nuvasive, Inc. · Modulus ALIF, 10x34x24mm 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 00887517018168), received between Jan 27, 2022 and Jan 27, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Contamination” (2 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, 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.
Most reported problems
Device problems
- Contamination2
Patient problems
- Unspecified Infection2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 27, 2022Contamination; Contamination
ON (B)(6) A PATIENT UNDERWENT A POSTEROLATERAL SPINE FUSION PROCEDURE FROM L3-5. ON (B)(6) 2021 IT WAS DISCOVERED THE PATIENT HAD DEVELOPED OSTEOMYELITIS AROUND TWO PREVIOUSLY IMPLANTED SPACER IMPLANTS AT THE L3-L5 LEVELS. ON (B)(6) 2022 A PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS THE BONE INFECTION. DURING THE REVISION PROCEDURE THE CONSTRUCT WAS EXTENDED TO L2-PELVIS PSF AND THE PREVIOUSLY IMPLANTED CAGES REMAINED IN PATIENT. THE PATIENT WAS TREATED FOR THE INFECTION WITH VANCOMYCIN AND IS RECOVERING. THE ROOT CAUSE OF THE OSTEOMYELITIS COULD NOT BE CONFIRMED.
Patient problems: Unspecified Infection
MAUDE report 13369860 ↗InjuryJan 27, 2022Contamination; Contamination
ON (B)(6) A PATIENT UNDERWENT A POSTEROLATERAL SPINE FUSION PROCEDURE FROM L3-L5. ON (B)(6) 2021 IT WAS DISCOVERED THE PATIENT HAD DEVELOPED OSTEOMYELITIS AROUND TWO IMPLANTED SPACER IMPLANTS AT THE L3-L5. ON (B)(6) 2022 A PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS THE BONE INFECTION. DURING THE REVISION PROCEDURE THE CONSTRUCT WAS EXTENDED TO L2-PELVIS PSF AND THE PREVIOUSLY IMPLANTED CAGES REMAINED IN PATIENT. THE PATIENT WAS TREATED FOR THE INFECTION WITH VANCOMYCIN AND IS RECOVERING. THE ROOT CAUSE OF THE OSTEOMYELITIS COULD NOT BE CONFIRMED.
Patient problems: Unspecified Infection
MAUDE report 13369161 ↗
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- 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
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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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