SMR System · 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.

11 linked reportsInjury 11

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	1.82
2019-02	0	1.85
2019-03	1	1.75
2019-04	3	1.88
2019-05	0	2.1
2019-06	0	1.88
2019-07	0	1.68
2019-08	0	2.18
2019-09	2	1.67
2019-10	0	1.88
2019-11	0	1.72
2019-12	0	1.77
2020-01	0	1.96
2020-02	0	2.08
2020-03	0	2.19
2020-04	0	1.8
2020-05	0	1.66
2020-06	0	1.95
2020-07	0	2.24
2020-08	0	1.76
2020-09	0	1.96
2020-10	0	2.2
2020-11	0	1.9
2020-12	0	1.87
2021-01	0	2.2
2021-02	0	1.99
2021-03	0	2.15
2021-04	0	2.02
2021-05	0	2.02
2021-06	0	1.91
2021-07	0	2.06
2021-08	0	2.19
2021-09	0	1.97
2021-10	0	2.18
2021-11	0	2.13
2021-12	1	2.6
2022-01	0	2.65
2022-02	0	2.35
2022-03	1	2.51
2022-04	0	2.48
2022-05	0	2.13
2022-06	0	2.24
2022-07	0	2.2
2022-08	0	2.27
2022-09	0	2.04
2022-10	0	2.12
2022-11	0	2.16
2022-12	0	2.1
2023-01	0	1.85
2023-02	0	2.06
2023-03	0	2.05
2023-04	0	2.22
2023-05	0	2.12
2023-06	0	2.32
2023-07	0	2.11
2023-08	0	1.76
2023-09	0	1.59
2023-10	0	1.64
2023-11	0	1.69
2023-12	0	1.46
2024-01	0	1.9
2024-02	0	1.89
2024-03	0	1.73
2024-04	0	1.87
2024-05	0	1.72
2024-06	0	1.89
2024-07	0	1.63
2024-08	0	1.73
2024-09	0	1.74
2024-10	0	1.73
2024-11	1	1.64
2024-12	0	1.67
2025-01	1	1.74
2025-02	0	1.65
2025-03	1	1.94
2025-04	0	1.73
2025-05	0	1.83
2025-06	0	1.96
2025-07	0	1.8
2025-08	0	1.61
2025-09	0	1.52
2025-10	0	1.69
2025-11	0	1.74
2025-12	0	2.19
2026-01	0	1.93
2026-02	0	1.85
2026-03	0	1.8
2026-04	0	1.74
2026-05	0	1.8
2026-06	0	1.8

This device (reports/month)Average device in KWS, PHX (reports/device/month)

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2025-03-27	3008021110-2025-00024	Injury	Available	exact di
2025-01-07	3008021110-2024-00110	Injury	Available	exact di
2024-11-08	3008021110-2024-00097	Injury	Available	exact di
2022-03-04	3008021110-2022-00012	Injury	Available	model number
2021-12-02	3008021110-2021-00097	Injury	Available	model number
2019-09-25	3008021110-2019-00110	Injury	Available	model number
2019-09-23	3008021110-2019-00108	Injury	Available	model number
2019-04-15	3008021110-2019-00040	Injury	Available	model number
2019-04-12	3008021110-2019-00044	Injury	Available	model number
2019-04-05	3008021110-2019-00045	Injury	Available	model number
2019-03-28	3008021110-2019-00028	Injury	Available	model number

Regulatory clearances

510(k)K113254Substantially equivalent (SESE) · 2012-02-24clearance family

Predicate lineage

K113254

Cited as predicate by: K142139, K143256, K153602, K153722, K170893, K172054, K172456, K183042, K190286, K191247, K193560, K201905, K212569, K220452, K221758, K223876, K230315, K230831, K231112, K233408, K241143, K242813, 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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