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Armada 8252300Recalls & reported problems

Nuvasive, Inc. · ARM15T CoCr Rod, 300mm Straight · 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 00887517219565), received between Mar 2, 2019 and Mar 2, 2019 — 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

  • Appropriate Device Problem Term/Code Not Available1
  • No Apparent Adverse Event1

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.

  • InjuryMar 2, 2019No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available; No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available

    RECEIVED NEW INFORMATION INDICATING PATIENT UNDERWENT A REVISION PROCEDURE ON 09/04/2018. IT IS UNKNOWN IF A NUVASIVE PRODUCT WAS USED AT THE TIME OF THE REVISION PROCEDURE.

    Patient problems: Failure of Implant

    MAUDE report 8384724 ↗

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