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Leverage 7650505PRecalls & reported problems

Nuvasive, Inc. · LeVerage Screw, 2.6x5mm Lateral Mass · 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 00887517995605), received between Nov 15, 2022 and Nov 15, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Migration” (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

  • Migration1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionNov 15, 2022Migration; Migration

    IT WAS REPORTED THAT A PATIENT UNDERWENT A THREE (3) LEVEL PROCEDURE AT C4/C6 ON (B)(6)2022. DURING A SUBSEQUENT APPOINTMENT ON (B)(6) 2022, IT WAS IDENTIFIED THAT THE A SCREW HAD MIGRATED AND WAS OUTSIDE OF THE PLATE. IT WAS REPORTED THAT THE MIGRATION HAD STOPPED AND THAT THE PATIENT WAS UNDER OBSERVATION. THE PATIENT WAS NOT REPORTED TO BE EXPERIENCING ANY PAIN OR ADVERSE CONSEQUENCES AS A RESULT OF THE DEVICE MIGRATION. NO PLANS FOR A REVISION SURGERY HAVE BEEN REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15801606 ↗

Other ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL devices

All ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL devices →

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