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.
548 linked reportsMalfunction 541Injury 7
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
5
2.43
2019-02
1
2.31
2019-03
6
2.25
2019-04
4
2.08
2019-05
2
2.21
2019-06
2
2.28
2019-07
0
2.37
2019-08
3
2.23
2019-09
26
2.68
2019-10
7
2.1
2019-11
10
2.09
2019-12
8
2.29
2020-01
15
2.34
2020-02
9
2.07
2020-03
3
2.14
2020-04
0
2.25
2020-05
9
2.09
2020-06
6
2.65
2020-07
4
3.62
2020-08
4
3.36
2020-09
4
3.49
2020-10
16
4.02
2020-11
13
3.63
2020-12
4
3.57
2021-01
4
3.73
2021-02
7
3.67
2021-03
4
3.23
2021-04
6
3.49
2021-05
6
3.18
2021-06
2
3.03
2021-07
5
2.66
2021-08
3
3.22
2021-09
8
2.79
2021-10
7
2.52
2021-11
2
3.11
2021-12
4
2.67
2022-01
5
2.6
2022-02
5
3.13
2022-03
8
3.17
2022-04
2
3.52
2022-05
9
3.71
2022-06
5
2.82
2022-07
3
2.5
2022-08
5
2.59
2022-09
8
2.82
2022-10
5
3.08
2022-11
4
3.6
2022-12
8
3.74
2023-01
8
4.57
2023-02
7
3.11
2023-03
5
3.63
2023-04
7
3.08
2023-05
6
3.19
2023-06
6
3.19
2023-07
6
2.85
2023-08
12
2.89
2023-09
4
2.22
2023-10
21
2.4
2023-11
4
3.21
2023-12
6
3.04
2024-01
6
2.84
2024-02
10
3.03
2024-03
2
2.79
2024-04
11
3.59
2024-05
6
3.57
2024-06
3
3.68
2024-07
8
2.83
2024-08
11
2.74
2024-09
9
3.06
2024-10
7
3.11
2024-11
7
2.81
2024-12
2
2.56
2025-01
6
2.86
2025-02
2
4.24
2025-03
1
5.06
2025-04
3
2.79
2025-05
7
2.85
2025-06
5
2.78
2025-07
5
2.56
2025-08
9
2.6
2025-09
4
2.15
2025-10
5
2.32
2025-11
4
2.66
2025-12
5
3.79
2026-01
2
3.54
2026-02
5
3.48
2026-03
1
3.22
2026-04
8
3.13
2026-05
6
2.6
2026-06
10
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
2026-06-25
1221934-2026-02785
Malfunction
—
catalog number
2026-06-15
1221934-2026-02587
Malfunction
Available
catalog number
2026-06-10
1221934-2026-02499
Malfunction
Available
catalog number
2026-06-10
1221934-2026-02492
Malfunction
Available
catalog number
2026-06-02
1221934-2026-02367
Malfunction
Available
catalog number
2026-05-29
1221934-2026-02334
Malfunction
Available
catalog number
2026-05-13
1221934-2026-02020
Malfunction
Available
catalog number
2026-05-11
1221934-2026-01980
Malfunction
Available
catalog number
2026-04-22
1221934-2026-01617
Malfunction
Available
catalog number
2026-04-20
1221934-2026-01559
Malfunction
Available
catalog number
2026-04-16
1221934-2026-01494
Malfunction
Available
catalog number
2026-04-02
1221934-2026-01364
Malfunction
Available
catalog number
2026-03-02
1221934-2026-00922
Malfunction
Available
exact di
2026-02-25
1221934-2026-00892
Malfunction
Available
catalog number
2026-02-23
1221934-2026-00853
Malfunction
Available
exact di
Showing the most recent 200 of 548 linked reports.