MAS PLIF 7094540Recalls & reported problems
Nuvasive, Inc. · MAS PLIF Shank, 4.5x40mm 3Z · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517173966), received between Mar 30, 2016 and Sep 14, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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 18, 2026.
Most reported problems
Device problems
- Fracture1
- Migration or Expulsion of Device1
Patient problems
- Failure of Implant2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2017Fracture; Fracture
ON (B)(6) 2017, A PATIENT UNDERWENT A MAXIMUM ACCESS SURGERY POSTERIOR LUMBAR INTERBODY FUSION (MAS PLIF) AT L4-L5 LEVELS. DURING A FOLLOW UP APPOINTMENT RADIOGRAPHS INDICATED THE RIGHT SCREW AT THE L5 LEVEL FRACTURED. NO PATIENT INJURY OR REVISION PROCEDURE WAS REPORTED.
Patient problems: Failure of Implant
MAUDE report 6866552 ↗MalfunctionMar 30, 2016Migration or Expulsion of Device; Migration or Expulsion of Device
A PATIENT UNDERWENT FUSION WITH INTERBODY CAGE AND PEDICLE SCREW FIXATION AT L4-L5. SURGEON REPORTED THE INFERIOR SCREW AT L5 PULLED OUT ALLOWING THE CAGE TO MIGRATE. REVISION SURGERY WAS COMPLETED TO REPLACE THE SCREWS.
Patient problems: Failure of Implant
MAUDE report 5536835 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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