Skip to content
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.

11 linked reportsMalfunction 10Injury 1
24682019-06: 2 reports for this device; peer average 2/device2019-07: 2 reports for this device; peer average 2/device2019-09: 2 reports for this device; peer average 2/device2019-10: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 2/device2020-04: 4 reports for this device; peer average 4/device2021-04: 0 reports for this device; peer average 2/device2022-02: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 4/device2023-11: 0 reports for this device; peer average 2/device2023-12: 0 reports for this device; peer average 4/device2024-01: 0 reports for this device; peer average 5/device2024-02: 0 reports for this device; peer average 2/device2024-04: 0 reports for this device; peer average 8/device2024-06: 0 reports for this device; peer average 2/device2024-07: 1 reports for this device; peer average 2/device2025-04: 0 reports for this device; peer average 4/device2025-05: 0 reports for this device; peer average 4/device2025-07: 0 reports for this device; peer average 2/device2025-08: 0 reports for this device; peer average 2/device2025-09: 0 reports for this device; peer average 2/device2025-10: 0 reports for this device; peer average 1/device2026-05: 0 reports for this device; peer average 4/device0607091002040402071112010204060704050708091005
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0622
2019-0722
2019-0922
2019-1001
2020-0202
2020-0444
2021-0402
2022-0201
2023-0704
2023-1102
2023-1204
2024-0105
2024-0202
2024-0408
2024-0602
2024-0712
2025-0404
2025-0504
2025-0702
2025-0802
2025-0902
2025-1001
2026-0504
This device (reports/month)Average device in IMI (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2024-07-139616086-2024-00053InjuryAvailableexact di
2020-04-219616086-2020-00015MalfunctionAvailableexact di
2020-04-219616086-2020-00014MalfunctionAvailableexact di
2019-09-259616086-2019-00067MalfunctionAvailableexact di
2019-07-059616086-2019-00047MalfunctionAvailableexact di
2019-06-139616086-2019-00025MalfunctionAvailableexact di

Showing the most recent 6 of 11 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
Similar devices
Select up to two to place side-by-side with this device.