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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

No recalls linked.

Regulatory clearances

    Predicate lineage

    Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

    Manufacturer compliance record
    DateTypeOutcomeFacilityCitations
    2025-10-16VAIVoluntary action indicatedGlobus Medical, Inc.1
    2025-10-16VAIVoluntary action indicatedGlobus Medical, Inc.1
    2025-08-13OAIOfficial action indicatedNevro Corporation6
    2025-03-25NAINo action indicatedNuvasive Manufacturing LLC.0
    2024-07-15WLWarning LetterGlobus Medical, Inc.—
    2024-07-15WLWarning LetterGlobus Medical, Inc.—
    2024-03-07OAIOfficial action indicatedGlobus Medical, Inc.6
    2024-03-07OAIOfficial action indicatedGlobus Medical, Inc.6
    2023-12-20VAIVoluntary action indicatedNevro Corporation1
    2022-07-29NAINo action indicatedNevro Medical SRL0
    2022-04-26NAINo action indicatedNevro Corporation0
    2019-10-23NAINo action indicatedGlobus Medical, Inc.0
    2019-10-23NAINo action indicatedGlobus Medical, Inc.0
    2019-09-27VAIVoluntary action indicatedGlobus Medical, Inc.7
    2019-09-27VAIVoluntary action indicatedGlobus Medical, Inc.7
    2019-03-21NAINo action indicatedNevro Corporation0
    2019-02-13VAIVoluntary action indicatedGlobus Medical, Inc.2
    2019-02-13VAIVoluntary action indicatedGlobus Medical, Inc.2
    2018-03-16NAINo action indicatedNevro Corporation0
    2017-11-03VAIVoluntary action indicatedNevro Corporation5
    2017-09-25NAINo action indicatedGlobus Medical, Inc.0
    2017-09-25NAINo action indicatedGlobus Medical, Inc.0
    2013-09-26WLWarning LetterGlobus Medical, Inc.—
    2013-09-26WLWarning LetterGlobus Medical, Inc.—
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