CHATTANOOGA · recalls, adverse events, clearances

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.

5 linked reportsMalfunction 5

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-02	0	1
2019-04	0	1.5
2019-05	2	1.5
2019-06	2	2
2019-07	0	4
2019-08	0	2
2019-09	0	2
2019-10	0	1.5
2019-12	0	1
2020-01	0	1
2020-06	0	1
2020-08	0	1
2020-12	0	1
2021-01	0	1
2021-02	0	1
2021-03	0	1
2021-04	0	1
2021-06	0	1
2021-09	0	1
2021-11	0	1
2021-12	0	1.5
2022-01	0	2
2022-02	0	1
2022-03	0	2
2022-04	0	1
2022-05	0	1
2022-06	0	1
2022-07	0	1
2022-09	0	1
2022-10	0	1
2022-12	0	1.25
2023-01	0	1
2023-02	0	1
2023-03	0	1.5
2023-04	0	1
2023-05	0	1
2023-11	0	1
2024-01	0	1
2024-02	0	2
2024-03	0	1
2024-04	0	1
2024-05	0	1.67
2024-06	0	1
2024-09	0	1
2024-10	0	1
2024-11	1	1
2025-01	0	1
2025-02	0	1
2025-05	0	1
2025-06	0	1
2025-07	0	1
2025-09	0	1
2025-10	0	1
2025-11	0	1
2026-01	0	1
2026-02	0	3
2026-03	0	3.67
2026-04	0	3.33
2026-05	0	2.67
2026-06	0	1.5

This device (reports/month)Average device in IRT (reports/device/month)

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2024-11-04	9616086-2024-00103	Malfunction	Available	exact di
2019-06-03	2020737-2019-00005	Malfunction	Available	exact di
2019-05-22	2020737-2019-00004	Malfunction	Available	exact di

Showing the most recent 3 of 5 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2022-04-29	NAI	No action indicated	DJO, LLC	0
2022-04-29	NAI	No action indicated	DJO, LLC	0
2017-09-26	VAI	Voluntary action indicated	DJO, LLC	3
2017-09-26	VAI	Voluntary action indicated	DJO, LLC	4
2017-09-26	VAI	Voluntary action indicated	DJO, LLC	4
2017-09-26	VAI	Voluntary action indicated	DJO, LLC	3
2013-09-06	VAI	Voluntary action indicated	DJO, LLC	6
2013-09-06	VAI	Voluntary action indicated	DJO, LLC	6
2011-07-14	VAI	Voluntary action indicated	DJO, LLC	4
2011-07-14	VAI	Voluntary action indicated	DJO, LLC	4

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