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.
421 linked reportsMalfunction 420Injury 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
17
2.43
2019-02
8
2.31
2019-03
5
2.25
2019-04
5
2.08
2019-05
4
2.21
2019-06
1
2.28
2019-07
6
2.37
2019-08
1
2.23
2019-09
10
2.68
2019-10
7
2.1
2019-11
8
2.09
2019-12
3
2.29
2020-01
6
2.34
2020-02
4
2.07
2020-03
5
2.14
2020-04
2
2.25
2020-05
2
2.09
2020-06
2
2.65
2020-07
7
3.62
2020-08
4
3.36
2020-09
3
3.49
2020-10
7
4.02
2020-11
7
3.63
2020-12
2
3.57
2021-01
7
3.73
2021-02
5
3.67
2021-03
5
3.23
2021-04
4
3.49
2021-05
2
3.18
2021-06
6
3.03
2021-07
4
2.66
2021-08
0
3.22
2021-09
5
2.79
2021-10
2
2.52
2021-11
4
3.11
2021-12
7
2.67
2022-01
1
2.6
2022-02
5
3.13
2022-03
7
3.17
2022-04
6
3.52
2022-05
3
3.71
2022-06
6
2.82
2022-07
1
2.5
2022-08
7
2.59
2022-09
6
2.82
2022-10
6
3.08
2022-11
12
3.6
2022-12
8
3.74
2023-01
12
4.57
2023-02
12
3.11
2023-03
13
3.63
2023-04
6
3.08
2023-05
10
3.19
2023-06
3
3.19
2023-07
5
2.85
2023-08
10
2.89
2023-09
2
2.22
2023-10
10
2.4
2023-11
5
3.21
2023-12
3
3.04
2024-01
0
2.84
2024-02
6
3.03
2024-03
2
2.79
2024-04
6
3.59
2024-05
7
3.57
2024-06
1
3.68
2024-07
2
2.83
2024-08
5
2.74
2024-09
3
3.06
2024-10
3
3.11
2024-11
8
2.81
2024-12
0
2.56
2025-01
2
2.86
2025-02
2
4.24
2025-03
4
5.06
2025-04
3
2.79
2025-05
1
2.85
2025-06
4
2.78
2025-07
2
2.56
2025-08
3
2.6
2025-09
0
2.15
2025-10
1
2.32
2025-11
2
2.66
2025-12
1
3.79
2026-01
1
3.54
2026-02
0
3.48
2026-03
7
3.22
2026-04
6
3.13
2026-05
2
2.6
2026-06
1
3.35
This device (reports/month)Average device in LXH (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
2026-06-17
1221934-2026-02645
Malfunction
Available
exact di
2026-05-22
1221934-2026-02157
Malfunction
Available
exact di
2026-05-04
1221934-2026-01854
Malfunction
Available
exact di
2026-04-29
1221934-2026-01746
Malfunction
Available
exact di
2026-04-29
1221934-2026-01759
Malfunction
Available
exact di
2026-04-28
1221934-2026-01748
Malfunction
Available
exact di
2026-04-16
1221934-2026-01495
Malfunction
Available
exact di
2026-04-09
1221934-2026-01466
Malfunction
Available
exact di
2026-04-06
1221934-2026-01405
Malfunction
Available
exact di
2026-03-25
1221934-2026-01226
Malfunction
Available
exact di
2026-03-19
1221934-2026-01161
Malfunction
Available
exact di
2026-03-12
1221934-2026-01046
Malfunction
Available
exact di
2026-03-12
1221934-2026-01045
Malfunction
Available
exact di
2026-03-12
1221934-2026-01044
Malfunction
Available
exact di
2026-03-11
1221934-2026-01018
Malfunction
Available
exact di
Showing the most recent 200 of 421 linked reports.