Skip to content

Armada 8452500Recalls & reported problems

Nuvasive, Inc. · ARM15T Rod, 500mm · 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 00887517266514), received between Jul 27, 2017 and Jul 27, 2017 — classified as 1 malfunction.

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

  • Break1

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.

  • MalfunctionJul 27, 2017Break; Break

    RECEIVED INFORMATION FROM PATIENT STATING HE WAS INFORMED OF SCREW LOOSENING AND WAS SEEKING ADVICE FROM NUVASIVE TO CONSULT WITH SURGEON IN REGARDS TO CURRENT SITUATION. NO REVISION SURGERY HAS BEEN REPORTED.

    Patient problems: Failure of Implant

    MAUDE report 6748511 ↗

Other Orthosis, spinal pedicle fixation, for degenerative disc disease devices

All Orthosis, spinal pedicle fixation, for degenerative disc disease devices →

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