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EVEREST® Spinal System E5112-07540Recalls & reported problems

VB Spine LLC · Polyaxial Screw, Extended Tab, Fenestrated Size Ø7.5x40 mm · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888857270701), received between Dec 19, 2016 and Dec 19, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Operates Differently Than Expected1

Patient problems

  • No Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 19, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

    ON (B)(6) 2016 IT WAS REPORTED TO K2M, INC. THAT A SURGERY TOOK PLACE IN WHICH THE SURGERY TIME WAS EXTENDED BY 25% DUE TO SCREW NOT FUNCTIONING AS INTENDED. SURGERY TOOK PLACE ON (B)(6) 2016.

    Patient problems: No Information

    MAUDE report 6187352 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.