SMR Shoulder · 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	1.81
2019-02	0	1.46
2019-03	0	1.5
2019-04	0	1.82
2019-05	0	1.94
2019-06	0	1.81
2019-07	0	1.44
2019-08	0	2.06
2019-09	0	1.61
2019-10	0	1.81
2019-11	0	1.57
2019-12	0	1.78
2020-01	0	1.97
2020-02	0	2.14
2020-03	0	1.52
2020-04	0	1.59
2020-05	0	1.76
2020-06	0	2.06
2020-07	0	1.96
2020-08	0	1.97
2020-09	0	2.11
2020-10	0	2.07
2020-11	0	1.94
2020-12	0	1.8
2021-01	0	1.92
2021-02	0	1.88
2021-03	0	1.98
2021-04	0	2.01
2021-05	0	1.67
2021-06	0	1.48
2021-07	0	2.14
2021-08	0	2.32
2021-09	0	1.86
2021-10	0	2.06
2021-11	0	1.95
2021-12	0	2.04
2022-01	0	2.27
2022-02	0	2.41
2022-03	0	2.04
2022-04	0	2.14
2022-05	0	1.9
2022-06	0	2.32
2022-07	0	2.34
2022-08	0	2
2022-09	0	1.94
2022-10	0	1.78
2022-11	0	1.81
2022-12	0	1.85
2023-01	0	1.77
2023-02	0	1.64
2023-03	0	1.85
2023-04	0	1.86
2023-05	0	1.89
2023-06	0	1.98
2023-07	0	1.92
2023-08	0	1.57
2023-09	0	1.38
2023-10	0	1.53
2023-11	0	1.55
2023-12	0	1.36
2024-01	0	1.5
2024-02	0	1.61
2024-03	0	1.5
2024-04	0	1.76
2024-05	0	1.48
2024-06	0	1.86
2024-07	0	1.44
2024-08	0	1.63
2024-09	0	1.58
2024-10	0	1.65
2024-11	0	1.57
2024-12	0	1.61
2025-01	0	1.66
2025-02	0	1.59
2025-03	0	1.71
2025-04	0	1.78
2025-05	0	1.77
2025-06	0	1.73
2025-07	0	1.56
2025-08	0	1.68
2025-09	0	1.4
2025-10	0	1.49
2025-11	0	1.76
2025-12	0	2.04
2026-01	1	1.72
2026-02	0	1.64
2026-03	0	1.59
2026-04	0	1.69
2026-05	0	1.54
2026-06	0	1.62

This device (reports/month)Average device in HSD, KWT (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
2026-01-22	3008021110-2026-00011	Injury	Available	exact di

Regulatory clearances

Predicate lineage

K100858

Cited as predicate by: K101263, K110847, K111212, K112900, K142139, K153602, K153722, K170473, K170893, K172054, K181362, K183042, K190286, K191247, K191963, K193560, K200368, K201905, K212569, K212992, K220452, K221758, K230315, K231112, K233408, K241143, K242813, K243826, K243955, K251558, K260802

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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