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.
1,081 linked reportsMalfunction 1,054Injury 27
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
11
2.43
2019-02
1
2.31
2019-03
9
2.25
2019-04
1
2.08
2019-05
3
2.21
2019-06
1
2.28
2019-07
8
2.37
2019-08
2
2.23
2019-09
8
2.68
2019-10
3
2.1
2019-11
3
2.09
2019-12
3
2.29
2020-01
2
2.34
2020-02
2
2.07
2020-03
3
2.14
2020-04
2
2.25
2020-05
4
2.09
2020-06
1
2.65
2020-07
3
3.62
2020-08
1
3.36
2020-09
3
3.49
2020-10
10
4.02
2020-11
2
3.63
2020-12
2
3.57
2021-01
1
3.73
2021-02
3
3.67
2021-03
0
3.23
2021-04
2
3.49
2021-05
1
3.18
2021-06
4
3.03
2021-07
0
2.66
2021-08
2
3.22
2021-09
6
2.79
2021-10
1
2.52
2021-11
1
3.11
2021-12
2
2.67
2022-01
2
2.6
2022-02
2
3.13
2022-03
3
3.17
2022-04
0
3.52
2022-05
4
3.71
2022-06
5
2.82
2022-07
1
2.5
2022-08
4
2.59
2022-09
1
2.82
2022-10
5
3.08
2022-11
90
3.6
2022-12
187
3.74
2023-01
271
4.57
2023-02
77
3.11
2023-03
106
3.63
2023-04
53
3.08
2023-05
16
3.19
2023-06
21
3.19
2023-07
3
2.85
2023-08
16
2.89
2023-09
4
2.22
2023-10
8
2.4
2023-11
2
3.21
2023-12
8
3.04
2024-01
2
2.84
2024-02
6
3.03
2024-03
5
2.79
2024-04
5
3.59
2024-05
2
3.57
2024-06
2
3.68
2024-07
2
2.83
2024-08
3
2.74
2024-09
0
3.06
2024-10
0
3.11
2024-11
1
2.81
2024-12
4
2.56
2025-01
4
2.86
2025-02
5
4.24
2025-03
4
5.06
2025-04
1
2.79
2025-05
3
2.85
2025-06
2
2.78
2025-07
6
2.56
2025-08
6
2.6
2025-09
1
2.15
2025-10
2
2.32
2025-11
1
2.66
2025-12
1
3.79
2026-01
2
3.54
2026-02
4
3.48
2026-03
1
3.22
2026-04
3
3.13
2026-05
0
2.6
2026-06
3
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
2026-06-16
1221934-2026-02636
Malfunction
Available
exact di
2026-06-11
1221934-2026-02506
Malfunction
Available
exact di
2026-06-05
1221934-2026-02427
Malfunction
Available
exact di
2026-04-29
1221934-2026-01779
Malfunction
Available
exact di
2026-04-29
1221934-2026-01763
Malfunction
Available
exact di
2026-04-27
1221934-2026-01650
Malfunction
Available
exact di
2026-03-23
1221934-2026-01192
Malfunction
Available
exact di
2026-02-24
1221934-2026-00867
Malfunction
Available
exact di
2026-02-09
1221934-2026-00657
Malfunction
Available
exact di
2026-02-09
1221934-2026-00658
Malfunction
Available
exact di
2026-02-06
1221934-2026-00602
Malfunction
Available
exact di
2026-01-22
1221934-2026-00322
Malfunction
Available
exact di
2026-01-07
1221934-2026-00104
Malfunction
Available
exact di
2025-12-29
1221934-2025-05000
Malfunction
Available
exact di
2025-11-10
1221934-2025-04300
Malfunction
Available
exact di
Showing the most recent 200 of 1,081 linked reports.