34546540503221 · 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.

15 linked reportsMalfunction 14Injury 1

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	9.11
2019-02	0	9.71
2019-03	0	9.79
2019-04	0	11.87
2019-05	1	13.04
2019-06	0	13.02
2019-07	0	9.88
2019-08	0	7.49
2019-09	1	7.85
2019-10	0	7.27
2019-11	1	9.91
2019-12	0	10.08
2020-01	0	8.04
2020-02	0	9.15
2020-03	0	9.62
2020-04	0	9.53
2020-05	0	11.43
2020-06	0	8.71
2020-07	1	9.7
2020-08	0	8.58
2020-09	0	8.91
2020-10	0	9.9
2020-11	0	10.94
2020-12	2	9.27
2021-01	0	9.05
2021-02	0	9.77
2021-03	1	9.35
2021-04	0	8.9
2021-05	0	9.8
2021-06	0	11.37
2021-07	0	8.74
2021-08	0	10.53
2021-09	0	13
2021-10	0	8.34
2021-11	0	11.01
2021-12	1	7.44
2022-01	0	6.82
2022-02	0	7.95
2022-03	0	9.35
2022-04	0	6.39
2022-05	0	8.87
2022-06	0	9.36
2022-07	0	8.79
2022-08	0	8.72
2022-09	0	8.74
2022-10	0	11.56
2022-11	0	10.32
2022-12	0	10.44
2023-01	0	9.14
2023-02	0	8.45
2023-03	0	10.04
2023-04	1	10.25
2023-05	0	10.82
2023-06	0	12.34
2023-07	0	14.14
2023-08	1	13.16
2023-09	0	11.4
2023-10	2	10.8
2023-11	2	14.61
2023-12	0	12.27
2024-01	0	16.51
2024-02	0	12.43
2024-03	0	14.98
2024-04	0	13.44
2024-05	0	12.95
2024-06	0	12.52
2024-07	0	13.91
2024-08	0	18.98
2024-09	0	14.7
2024-10	0	18.36
2024-11	0	10.72
2024-12	0	10.63
2025-01	0	12.32
2025-02	0	13.73
2025-03	0	12.56
2025-04	0	13.77
2025-05	0	13.22
2025-06	1	16.69
2025-07	0	12.44
2025-08	0	10.63
2025-09	0	11.02
2025-10	0	10.7
2025-11	0	9.45
2025-12	0	8.85
2026-01	0	10.24
2026-02	0	8.24
2026-03	0	8.88
2026-04	0	7.34
2026-05	0	7.59
2026-06	0	5.85

This device (reports/month)Average device in HAW, OLO (reports/device/month)

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2025-06-27	3015967359-2025-01187	Malfunction	Available	exact di
2023-11-20	3015967359-2023-02488	Injury	Available	exact di
2023-11-10	3015967359-2023-02457	Malfunction	Available	exact di
2023-10-24	17995027	Malfunction	Available	catalog number
2023-08-31	3015967359-2023-01918	Malfunction	Available	exact di
2023-04-19	0001811755-2023-00042	Malfunction	Available	exact di
2021-12-07	3015967359-2021-02680	Malfunction	Available	exact di
2021-03-25	3015967359-2021-00268	Malfunction	Available	exact di
2020-12-14	0001811755-2020-03414	Malfunction	Available	exact di
2020-12-04	0001811755-2020-03343	Malfunction	Available	exact di
2020-07-24	0001811755-2020-01808	Malfunction	Available	exact di
2019-11-25	0001811755-2019-03842	Malfunction	Available	exact di
2019-09-09	0001811755-2019-02932	Malfunction	Available	exact di
2019-05-23	0001811755-2019-01785	Malfunction	Available	exact di

Showing the most recent 14 of 15 linked reports.

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

Similar devices