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.
252 linked reportsMalfunction 235Injury 17
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
2.43
2019-02
0
2.31
2019-03
0
2.25
2019-04
0
2.08
2019-05
0
2.21
2019-06
0
2.28
2019-07
0
2.37
2019-08
0
2.23
2019-09
3
2.68
2019-10
2
2.1
2019-11
0
2.09
2019-12
4
2.29
2020-01
3
2.34
2020-02
0
2.07
2020-03
3
2.14
2020-04
3
2.25
2020-05
3
2.09
2020-06
1
2.65
2020-07
0
3.62
2020-08
0
3.36
2020-09
4
3.49
2020-10
9
4.02
2020-11
7
3.63
2020-12
0
3.57
2021-01
3
3.73
2021-02
1
3.67
2021-03
1
3.23
2021-04
2
3.49
2021-05
1
3.18
2021-06
2
3.03
2021-07
1
2.66
2021-08
1
3.22
2021-09
3
2.79
2021-10
2
2.52
2021-11
2
3.11
2021-12
0
2.67
2022-01
0
2.6
2022-02
1
3.13
2022-03
0
3.17
2022-04
2
3.52
2022-05
2
3.71
2022-06
3
2.82
2022-07
2
2.5
2022-08
1
2.59
2022-09
0
2.82
2022-10
2
3.08
2022-11
0
3.6
2022-12
1
3.74
2023-01
1
4.57
2023-02
1
3.11
2023-03
0
3.63
2023-04
1
3.08
2023-05
0
3.19
2023-06
2
3.19
2023-07
9
2.85
2023-08
0
2.89
2023-09
2
2.22
2023-10
7
2.4
2023-11
8
3.21
2023-12
2
3.04
2024-01
3
2.84
2024-02
8
3.03
2024-03
4
2.79
2024-04
3
3.59
2024-05
2
3.57
2024-06
2
3.68
2024-07
0
2.83
2024-08
5
2.74
2024-09
0
3.06
2024-10
1
3.11
2024-11
6
2.81
2024-12
3
2.56
2025-01
2
2.86
2025-02
6
4.24
2025-03
4
5.06
2025-04
3
2.79
2025-05
12
2.85
2025-06
5
2.78
2025-07
11
2.56
2025-08
6
2.6
2025-09
10
2.15
2025-10
6
2.32
2025-11
5
2.66
2025-12
10
3.79
2026-01
6
3.54
2026-02
0
3.48
2026-03
4
3.22
2026-04
4
3.13
2026-05
4
2.6
2026-06
9
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
2026-06-24
1221934-2026-02781
Malfunction
—
catalog number
2026-06-23
1221934-2026-02747
Malfunction
—
catalog number
2026-06-17
1221934-2026-02650
Malfunction
Available
catalog number
2026-06-16
1221934-2026-02602
Malfunction
Available
exact di
2026-06-16
1221934-2026-02630
Malfunction
Available
catalog number
2026-05-26
1221934-2026-02196
Malfunction
Available
catalog number
2026-05-11
1221934-2026-01982
Malfunction
Available
catalog number
2026-04-21
1221934-2026-01539
Malfunction
Available
catalog number
2026-04-21
1221934-2026-01557
Malfunction
Available
catalog number
2026-03-19
1221934-2026-01163
Malfunction
Available
catalog number
2026-03-17
1221934-2026-01092
Malfunction
Available
exact di
2026-03-17
1221934-2026-01112
Malfunction
Available
exact di
2026-01-27
1221934-2026-00406
Malfunction
Available
catalog number
2026-01-07
1221934-2026-00083
Malfunction
Available
catalog number
2026-01-07
1221934-2026-00101
Malfunction
Available
exact di
Showing the most recent 155 of 252 linked reports.