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.
140 linked reportsInjury 135Malfunction 5
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
0
1.75
2019-04
0
1.88
2019-05
0
2.1
2019-06
0
1.88
2019-07
0
1.68
2019-08
0
2.18
2019-09
1
1.67
2019-10
0
1.88
2019-11
2
1.72
2019-12
0
1.77
2020-01
0
1.96
2020-02
1
2.08
2020-03
2
2.19
2020-04
2
1.8
2020-05
0
1.66
2020-06
1
1.95
2020-07
0
2.24
2020-08
0
1.76
2020-09
1
1.96
2020-10
2
2.2
2020-11
0
1.9
2020-12
0
1.87
2021-01
0
2.2
2021-02
1
1.99
2021-03
4
2.15
2021-04
1
2.02
2021-05
2
2.02
2021-06
0
1.91
2021-07
3
2.06
2021-08
2
2.19
2021-09
0
1.97
2021-10
1
2.18
2021-11
0
2.13
2021-12
2
2.6
2022-01
0
2.65
2022-02
4
2.35
2022-03
0
2.51
2022-04
1
2.48
2022-05
5
2.13
2022-06
3
2.24
2022-07
0
2.2
2022-08
4
2.27
2022-09
1
2.04
2022-10
0
2.12
2022-11
2
2.16
2022-12
0
2.1
2023-01
0
1.85
2023-02
2
2.06
2023-03
2
2.05
2023-04
2
2.22
2023-05
3
2.12
2023-06
3
2.32
2023-07
3
2.11
2023-08
1
1.76
2023-09
2
1.59
2023-10
4
1.64
2023-11
3
1.69
2023-12
1
1.46
2024-01
1
1.9
2024-02
2
1.89
2024-03
3
1.73
2024-04
4
1.87
2024-05
2
1.72
2024-06
3
1.89
2024-07
5
1.63
2024-08
0
1.73
2024-09
2
1.74
2024-10
3
1.73
2024-11
4
1.64
2024-12
1
1.67
2025-01
1
1.74
2025-02
1
1.65
2025-03
3
1.94
2025-04
2
1.73
2025-05
0
1.83
2025-06
1
1.96
2025-07
3
1.8
2025-08
3
1.61
2025-09
4
1.52
2025-10
2
1.69
2025-11
2
1.74
2025-12
2
2.19
2026-01
1
1.93
2026-02
1
1.85
2026-03
1
1.8
2026-04
1
1.74
2026-05
4
1.8
2026-06
4
1.8
This device (reports/month)Average device in KWS, PHX (reports/device/month)
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
Initiated
Recall #
Class
Status
Reason
Quantity
Link basis
2020-09-02
Z-0093-2021
Class II
Terminated
Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates and two (2) adaptersDistribution: US Nationwide distribution including in the states of CO, MN, OH, WY.
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.