07613327545883 · 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.

50 linked reportsMalfunction 50

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	2.67
2019-02	0	3.61
2019-03	0	3.19
2019-04	0	2.75
2019-05	0	3.1
2019-06	0	2.72
2019-07	0	3.23
2019-08	0	2.93
2019-09	0	2.89
2019-10	0	3.84
2019-11	0	5.54
2019-12	0	3.54
2020-01	0	3.39
2020-02	0	4.56
2020-03	0	4.41
2020-04	0	7.69
2020-05	0	2.37
2020-06	0	3.54
2020-07	0	3.94
2020-08	0	2.61
2020-09	0	3.93
2020-10	0	5.63
2020-11	0	5.77
2020-12	0	4.33
2021-01	0	4.68
2021-02	0	4.08
2021-03	0	3.82
2021-04	0	3.82
2021-05	0	4.15
2021-06	0	3.79
2021-07	0	3.25
2021-08	0	2.96
2021-09	0	2.92
2021-10	0	2.27
2021-11	0	4.24
2021-12	0	2.72
2022-01	0	2.54
2022-02	0	3.16
2022-03	0	3.32
2022-04	0	2.45
2022-05	0	3.91
2022-06	0	4.21
2022-07	0	3.33
2022-08	0	2.9
2022-09	1	2.32
2022-10	1	3.76
2022-11	2	3.44
2022-12	5	4.22
2023-01	2	3.18
2023-02	11	3.44
2023-03	1	3.77
2023-04	0	3.26
2023-05	0	3.02
2023-06	0	2.6
2023-07	0	2.69
2023-08	1	2.51
2023-09	1	4.04
2023-10	3	3.21
2023-11	2	9.13
2023-12	0	4
2024-01	0	3.71
2024-02	2	4.15
2024-03	1	4.4
2024-04	0	3.95
2024-05	1	4.89
2024-06	1	4.54
2024-07	1	3.92
2024-08	2	4.59
2024-09	4	4.53
2024-10	1	6.31
2024-11	0	4.74
2024-12	0	4.01
2025-01	0	8.37
2025-02	1	4.23
2025-03	2	3.59
2025-04	0	4.2
2025-05	3	4.57
2025-06	0	4.14
2025-07	0	4.32
2025-08	1	5.03
2025-09	0	3.85
2025-10	0	3.97
2025-11	0	4.12
2025-12	0	4.59
2026-01	0	4.53
2026-02	0	4.25
2026-03	0	4.08
2026-04	0	3.9
2026-05	0	4.99
2026-06	0	3.99

This device (reports/month)Average device in OLO (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
2025-08-07	0008010177-2025-00097	Malfunction	Available	exact di
2025-05-12	0008010177-2025-00071	Malfunction	Available	exact di
2025-05-09	0008010177-2025-00070	Malfunction	Available	exact di
2025-05-01	0008010177-2025-00069	Malfunction	Available	exact di
2025-03-21	0008010177-2025-00034	Malfunction	Available	exact di
2025-03-21	0008010177-2025-00033	Malfunction	Available	exact di
2025-02-11	0008010177-2025-00019	Malfunction	Available	exact di
2024-10-29	0008010177-2024-00120	Malfunction	Available	exact di
2024-09-26	0008010177-2024-00105	Malfunction	Available	exact di
2024-09-13	0008010177-2024-00100	Malfunction	Available	exact di
2024-09-11	0008010177-2024-00098	Malfunction	Available	exact di
2024-09-11	0008010177-2024-00099	Malfunction	Available	exact di
2024-08-28	0008010177-2024-00088	Malfunction	Available	exact di
2024-08-15	0008010177-2024-00083	Malfunction	Available	exact di
2024-07-31	0008010177-2024-00073	Malfunction	Available	exact di

Showing 1–15 of 50

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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