MAS PLIF 7095535Recalls & reported problems
Nuvasive, Inc. · MAS PLIF Shank, 5.5x35mm 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 00887517175137), received between Apr 17, 2018 and Apr 17, 2018 — classified as 1 malfunction.
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 16, 2026.
Most reported problems
Device problems
- Fracture1
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 17, 2018Fracture; Fracture
ON (B)(6) 2017 PATIENT UNDERWENT A POSTERIOR LUMBAR INTERBODY FUSION. DURING THE SIX MONTH FOLLOW UP IT WAS DISCOVERED THAT ONE OF THE IMPLANTED MAS PLIF SHANKS HAD FRACTURED. THE PATIENT IS CURRENTLY ASYMPTOMATIC AND NO REVISION PROCEDURE IS PLANNED AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 7437396 ↗
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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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