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External Remote Controller P003Recalls & reported problems

Nuvasive Specialized Orthopedics, Inc. · External Remote Controller · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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 00856719002039), received between Jul 30, 2020 and Jul 30, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Mechanical Problem1

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 30, 2020Mechanical Problem; Mechanical Problem

    INFORMATION WAS RECEIVED THAT PRODUCT IS NO LONGER LENGTHENING. NO PATIENT INJURY WAS REPORTED.

    Patient problems: Failure of Implant

    MAUDE report 10348374 ↗

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Sources and updates

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