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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.

4 linked reportsMalfunction 4
11222019-05: 0 reports for this device; peer average 2/device2019-06: 0 reports for this device; peer average 1/device2019-07: 0 reports for this device; peer average 2/device2019-08: 2 reports for this device; peer average 2/device2019-11: 0 reports for this device; peer average 1/device2019-12: 2 reports for this device; peer average 2/device2025-12: 0 reports for this device; peer average 2/device05060708111212
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0502
2019-0601
2019-0702
2019-0822
2019-1101
2019-1222
2025-1202
This device (reports/month)Average device in IRQ (reports/device/month)
Failure-mode summaryAI-generated

4 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2019-12-309616086-2019-00090MalfunctionAvailableexact di
2019-08-219616086-2019-00057MalfunctionAvailableexact di

Showing the most recent 2 of 4 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2022-04-29NAINo action indicatedDJO, LLC0
2022-04-29NAINo action indicatedDJO, LLC0
2017-09-26VAIVoluntary action indicatedDJO, LLC3
2017-09-26VAIVoluntary action indicatedDJO, LLC4
2017-09-26VAIVoluntary action indicatedDJO, LLC4
2017-09-26VAIVoluntary action indicatedDJO, LLC3
2013-09-06VAIVoluntary action indicatedDJO, LLC6
2013-09-06VAIVoluntary action indicatedDJO, LLC6
2011-07-14VAIVoluntary action indicatedDJO, LLC4
2011-07-14VAIVoluntary action indicatedDJO, LLC4
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