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Armada 8854535Recalls & reported problems

Nuvasive, Inc. · ARM15T Screw, 4.5x35mm Fixed · 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 00887517380470), received between Mar 12, 2021 and Mar 12, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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

  • Material Twisted/Bent1

Patient problems

  • Hypoesthesia1
  • 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.

  • MalfunctionMar 12, 2021Material Twisted/Bent; Material Twisted/Bent

    ON (B)(6) 2021 A SPINAL PROCEDURE WAS DONE ON A PATIENT WITH SCOLIOSIS. POST-OP IMAGES REVEAL THAT THE SCREWS WERE BENT INSIDE THE VERTEBRAE. ON (B)(6) 2021 A REVISION PROCEDURE WAS DONE WHERE THE NUVASIVE SCREWS WERE REPLACED WITH A COMPETITORS' BRAND. NO PATIENT INJURY OR SYMPTOMS WERE REPORTED.

    Patient problems: Hypoesthesia; No Clinical Signs, Symptoms or Conditions

    MAUDE report 11476330 ↗

Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices

All APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices →

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