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EVEREST® Spinal System E5111-06540Recalls & reported problems

VB Spine LLC · E5111-06540 · Class 2 · Implant

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 10888857212596), received between Aug 11, 2020 and Aug 11, 2020 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Fracture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionAug 11, 2020Fracture; Fracture

    A PHYSICIAN REPORT THAT THE EXTENDED TAB OF AN EVEREST XT FENESTRATED POLYAXIAL SCREW FRACTURED UNEVENLY DURING SURGERY. THE INCISION SITE WAS INCREASED TO BETTER VISUALIZE THE TULIP AND THE REMAINING FRAGMENT OF THE TAB WAS REMOVED SUCCESSFULLY FOLLOWING A 15-MINUTE SURGICAL DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

    MAUDE report 10391960 ↗

Other Orthosis, spondylolisthesis spinal fixation devices

All Orthosis, spondylolisthesis spinal fixation devices →

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