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Armada 8456550Recalls & reported problems

Nuvasive, Inc. · ARM15T Screw, 6.5x50mm Polyaxial · 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 00887517271075), received between Sep 26, 2017 and Sep 26, 2017 — classified as 1 injury.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Bone Fracture(s)1

Recent adverse event reports

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

  • InjurySep 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ON (B)(6) 2017, A PATIENT UNDERWENT A 2 LEVEL EXTREME LATERAL INTERBODY FUSION AT L2-L4 LEVELS AND A 2 LEVEL TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4-S1 LEVELS WITH MEDIAL LATERAL EXPANDABLE INTERBODY. DURING A FOLLOW UP THE PATIENT EXPRESSED BACK PAIN, RADIOGRAPHS SHOWED THERE WAS A LOOSE SCREW AND A FRACTURED PEDICLE AT L4 LEVEL.

    Patient problems: Bone Fracture(s)

    MAUDE report 6895618 ↗

Other Orthosis, spondylolisthesis spinal fixation devices

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