S-Series · 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.

95 linked reportsMalfunction 88Injury 7

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	4	4
2020-10	4	4
2020-11	16	16
2020-12	8	8
2021-01	0	1
2021-02	16	16
2021-03	24	24
2021-04	12	5.33
2021-06	4	4
2021-07	4	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	3	2.33
2024-03	0	1.64
2024-04	0	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

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2024-02-16	0002031963-2024-00001	Injury	Available	catalog number
2021-07-08	0002031963-2021-00015	Malfunction	Available	catalog number
2021-06-17	0002031963-2021-00014	Malfunction	Available	catalog number
2021-04-28	0002031963-2021-00013	Malfunction	Available	catalog number
2021-04-23	0002031963-2021-00012	Malfunction	Available	catalog number
2021-04-15	0002031963-2021-00011	Malfunction	Available	catalog number
2021-03-16	0002031963-2021-00010	Malfunction	Available	catalog number
2021-03-11	0002031963-2021-00009	Malfunction	Available	catalog number
2021-03-03	0002031963-2021-00006	Malfunction	Available	catalog number
2021-03-03	0002031963-2021-00005	Malfunction	Available	catalog number
2021-03-03	0002031963-2021-00007	Malfunction	Available	catalog number
2021-03-03	0002031963-2021-00008	Malfunction	Available	catalog number
2021-02-16	0002031963-2021-00004	Malfunction	Available	catalog number
2021-02-10	0002031963-2021-00003	Malfunction	Available	catalog number
2021-02-10	0002031963-2021-00002	Malfunction	Available	catalog number

Showing the most recent 24 of 95 linked reports.

Showing 1–15 of 24

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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