MAS PLIF 7094535Recalls & reported problems
Nuvasive, Inc. · MAS PLIF Shank, 4.5x35mm 3Z · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517173959), received between Apr 16, 2018 and Apr 16, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 16, 2018Break; Break
ON (B)(6) 2017 PATIENT UNDERWENT A POSTERIOR LUMBAR INTERBODY FUSION ON L3-L5 LEVELS. DURING A SIX MONTH FOLLOW UP IT WAS DISCOVERED THAT A SCREW AT THE L5 LEVEL HAD FRACTURED. THE PATIENT IS ASYMPTOMATIC AND NO REVISION PROCEDURE IS PLANNED AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 7434335 ↗
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- Elegance® Anterior Cervical Plate 53430112Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
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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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