07613327292183 · 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.

40 linked reportsMalfunction 40

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-01	0	2.71
2019-02	0	3.5
2019-03	0	2.8
2019-04	0	1.75
2019-05	20	2.27
2019-06	5	1.56
2019-07	2	1.53
2019-08	13	3.77
2019-09	0	2.71
2019-10	0	3.56
2019-11	0	3.79
2019-12	0	4.23
2020-01	0	2.65
2020-02	0	1.91
2020-03	0	3.32
2020-04	0	2.39
2020-05	0	1.5
2020-06	0	1.63
2020-07	0	2.13
2020-08	0	2.69
2020-09	0	2.65
2020-10	0	3.66
2020-11	0	2.63
2020-12	0	2.47
2021-01	0	1.14
2021-02	0	2
2021-03	0	1.65
2021-04	0	1.82
2021-05	0	1.52
2021-06	0	2.11
2021-07	0	2.59
2021-08	0	2.29
2021-09	0	3.6
2021-10	0	2.45
2021-11	0	1.79
2021-12	0	1.48
2022-01	0	1.95
2022-02	0	1.76
2022-03	0	1.35
2022-04	0	2.33
2022-05	0	2.78
2022-06	0	2.11
2022-07	0	1.69
2022-08	0	2.16
2022-09	0	2.15
2022-10	0	2.3
2022-11	0	2
2022-12	0	1.87
2023-01	0	2.6
2023-02	0	2.05
2023-03	0	2.41
2023-04	0	1.8
2023-05	0	2.31
2023-06	0	2.31
2023-07	0	1.73
2023-08	0	2.77
2023-09	0	3.18
2023-10	0	6.98
2023-11	0	5.55
2023-12	0	7.02
2024-01	0	5.24
2024-02	0	6.77
2024-03	0	5.45
2024-04	0	7.76
2024-05	0	7.8
2024-06	0	5.96
2024-07	0	9.32
2024-08	0	12.11
2024-09	0	15.27
2024-10	0	13.26
2024-11	0	11.41
2024-12	0	8.76
2025-01	0	8.61
2025-02	0	16.3
2025-03	0	11.36
2025-04	0	10.76
2025-05	0	8.22
2025-06	0	8.79
2025-07	0	16.53
2025-08	0	8.4
2025-09	0	9.59
2025-10	0	14.94
2025-11	0	12.39
2025-12	0	11.91
2026-01	0	9.51
2026-02	0	8.11
2026-03	0	11.18
2026-04	0	10.69
2026-05	0	10.77
2026-06	0	12.25

This device (reports/month)Average device in ETN (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
2019-08-27	0001811755-2019-02816	Malfunction	Available	exact di
2019-08-27	0001811755-2019-02811	Malfunction	Available	exact di
2019-08-27	0001811755-2019-02815	Malfunction	Available	exact di
2019-08-27	0001811755-2019-02806	Malfunction	Available	exact di
2019-08-27	0001811755-2019-02813	Malfunction	Available	exact di
2019-08-27	0001811755-2019-02817	Malfunction	Available	exact di
2019-08-27	0001811755-2019-02810	Malfunction	Available	exact di
2019-08-27	0001811755-2019-02818	Malfunction	Available	exact di
2019-08-27	0001811755-2019-02809	Malfunction	Available	exact di
2019-08-27	0001811755-2019-02819	Malfunction	Available	exact di
2019-08-27	0001811755-2019-02807	Malfunction	Available	exact di
2019-08-27	0001811755-2019-02814	Malfunction	Available	exact di
2019-08-27	0001811755-2019-02804	Malfunction	Available	exact di
2019-07-12	0001811755-2019-02276	Malfunction	Available	exact di
2019-07-02	0001811755-2019-02185	Malfunction	Available	exact di

Showing 1–15 of 40

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility
2025-02-27	NAI	No action indicated	Stryker Leibinger GmbH & Co. KG
2017-07-27	NAI	No action indicated	Stryker Leibinger GmbH & Co. KG
2013-11-14	NAI	No action indicated	Stryker Leibinger GmbH & Co. KG

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