H-MAX S Stem · 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.

1 linked reportInjury 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	2.46
2019-02	0	2.11
2019-03	0	2.29
2019-04	0	2.34
2019-05	0	1.87
2019-06	0	1.59
2019-07	0	1.68
2019-08	0	1.81
2019-09	0	1.89
2019-10	0	1.99
2019-11	0	1.73
2019-12	0	1.89
2020-01	0	2.1
2020-02	0	2.01
2020-03	0	2.56
2020-04	0	1.81
2020-05	0	1.88
2020-06	0	1.67
2020-07	0	2.03
2020-08	0	1.62
2020-09	0	1.84
2020-10	0	1.93
2020-11	0	1.82
2020-12	0	1.85
2021-01	0	1.94
2021-02	0	1.66
2021-03	0	1.69
2021-04	0	1.65
2021-05	0	1.67
2021-06	0	1.95
2021-07	0	1.78
2021-08	0	1.65
2021-09	0	1.88
2021-10	0	1.73
2021-11	0	1.73
2021-12	0	1.83
2022-01	0	1.6
2022-02	0	1.87
2022-03	0	1.61
2022-04	0	1.77
2022-05	0	1.72
2022-06	1	1.76
2022-07	0	1.66
2022-08	0	1.8
2022-09	0	1.77
2022-10	0	1.73
2022-11	0	1.82
2022-12	0	1.64
2023-01	0	1.72
2023-02	0	1.67
2023-03	0	1.76
2023-04	0	1.77
2023-05	0	1.8
2023-06	0	1.87
2023-07	0	1.85
2023-08	0	1.76
2023-09	0	1.82
2023-10	0	1.42
2023-11	0	1.39
2023-12	0	1.43
2024-01	0	1.51
2024-02	0	1.67
2024-03	0	1.83
2024-04	0	1.54
2024-05	0	1.96
2024-06	0	1.74
2024-07	0	1.52
2024-08	0	1.76
2024-09	0	1.78
2024-10	0	1.57
2024-11	0	1.41
2024-12	0	1.42
2025-01	0	1.56
2025-02	0	1.38
2025-03	0	1.68
2025-04	0	1.66
2025-05	0	1.41
2025-06	0	1.64
2025-07	0	1.62
2025-08	0	1.43
2025-09	0	1.59
2025-10	0	1.58
2025-11	0	1.7
2025-12	0	1.74
2026-01	0	1.81
2026-02	0	1.45
2026-03	0	1.9
2026-04	0	1.7
2026-05	0	1.54
2026-06	0	1.55

This device (reports/month)Average device in JDI, KWY, MEH (reports/device/month)

Failure-mode summaryAI-generated

1 linked report narrative available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2022-06-06	3008021110-2022-00044	Injury	Available	model number

Regulatory clearances

Predicate lineage

K160011

Cited as predicate by: K170473, K243809

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record

None in the loaded window.

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