Visum · 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.

3 linked reportsMalfunction 3

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
2019-03	0	1
2019-04	0	1
2019-05	0	2
2019-07	0	2
2019-08	0	2
2019-09	0	3
2019-11	0	1
2019-12	0	4
2020-02	0	3.5
2020-03	0	1
2020-05	0	1
2020-07	0	1.33
2020-08	0	1
2020-09	0	1
2020-10	0	1.75
2020-11	0	1
2020-12	0	1
2021-01	0	1
2021-02	0	1.67
2021-03	0	3
2021-04	0	1.2
2021-05	0	1.5
2021-06	0	2
2021-08	0	1.67
2021-09	0	1
2021-10	0	2.33
2021-12	0	1.25
2022-01	0	1.5
2022-02	0	1
2022-03	0	9.33
2022-04	0	1
2022-05	0	1
2022-06	0	1
2022-07	0	2.25
2022-08	0	2
2022-09	0	1.17
2022-10	0	1
2022-11	0	1
2022-12	0	1
2023-01	0	1.17
2023-02	0	3
2023-03	3	3
2023-04	0	1.25
2023-05	0	1.25
2023-06	0	1.79
2023-07	0	1.5
2023-08	0	2
2023-09	0	3.25
2023-10	0	1.8
2023-11	0	1.87
2023-12	0	1.67
2024-01	0	2
2024-02	0	1.67
2024-03	0	1.64
2024-04	0	2.64
2024-05	0	1.4
2024-06	0	1.78
2024-07	0	2.88
2024-08	0	2.38
2024-09	0	2.17
2024-10	0	1.55
2024-11	0	1.43
2024-12	0	2.5
2025-01	0	3.29
2025-02	0	2.06
2025-03	0	1.75
2025-04	0	3
2025-05	0	2
2025-06	0	2.5
2025-07	0	2.14
2025-08	0	1.57
2025-09	0	2
2025-10	0	2.3
2025-11	0	1.91
2025-12	0	2
2026-01	0	2.75
2026-02	0	1.56
2026-03	0	4.17
2026-04	0	2.67
2026-05	0	2
2026-06	0	4

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

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2023-03-10	0002031963-2023-00001	Malfunction	Available	catalog number

Showing the most recent 1 of 3 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2016-03-03	NAI	No action indicated	Stryker Communications	0
2012-11-13	NAI	No action indicated	Stryker Communications	0
2012-03-02	VAI	Voluntary action indicated	Stryker Communications	2

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