07613327166736 · 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.

2 linked reportsMalfunction 2

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2020-01	0	2
2020-03	0	1
2020-09	0	4
2020-10	0	4
2020-11	0	16
2020-12	0	8
2021-01	0	1
2021-02	0	16
2021-03	0	24
2021-04	0	5.33
2021-06	0	4
2021-07	0	4
2021-08	0	1
2021-10	0	1
2021-11	0	1
2021-12	0	1
2022-01	0	1
2022-02	0	5.67
2022-03	0	1
2022-04	0	1
2022-05	0	1.33
2022-06	0	1
2022-07	0	1.33
2022-08	0	1.4
2022-09	0	2.67
2022-10	0	1.17
2022-11	0	1
2022-12	0	1.2
2023-01	0	1.25
2023-02	0	1.14
2023-03	0	1.5
2023-04	0	1.29
2023-05	0	1.13
2023-06	0	1.08
2023-07	0	2.22
2023-08	0	1.75
2023-09	0	3.17
2023-10	0	1.68
2023-11	0	1.64
2023-12	0	2.78
2024-01	0	3.33
2024-02	0	2.33
2024-03	0	1.64
2024-04	2	1.64
2024-05	0	1.57
2024-06	0	1.71
2024-07	0	1.33
2024-08	0	1.89
2024-09	0	1.5
2024-10	0	2.17
2024-11	0	2
2024-12	0	1.67
2025-01	0	1.27
2025-02	0	2.31
2025-03	0	2
2025-04	0	1.4
2025-05	0	2.85
2025-06	0	2.67
2025-07	0	2
2025-08	0	1.67
2025-09	0	2.4
2025-10	0	1.75
2025-11	0	2.25
2025-12	0	2
2026-01	0	1.9
2026-02	0	2.11
2026-03	0	22.5
2026-04	0	2
2026-05	0	2.33
2026-06	0	2.11

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

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2024-04-09	0002031963-2024-00003	Malfunction	Available	catalog number

Showing the most recent 1 of 2 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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