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.
109 linked reportsInjury 109
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
4.02
2019-02
0
5.49
2019-03
0
4.31
2019-04
0
4.35
2019-05
0
4.17
2019-06
0
7.53
2019-07
0
6.39
2019-08
0
5.67
2019-09
4
101.74
2019-10
0
19.81
2019-11
0
16.08
2019-12
6
30.69
2020-01
0
21.27
2020-02
0
20.62
2020-03
2
27.38
2020-04
0
11.97
2020-05
0
16.48
2020-06
2
19.79
2020-07
0
20.77
2020-08
0
21.31
2020-09
0
21.29
2020-10
2
24.87
2020-11
6
25.78
2020-12
2
23.76
2021-01
0
25.39
2021-02
0
23.01
2021-03
0
26.58
2021-04
2
27.25
2021-05
0
26.71
2021-06
0
25.72
2021-07
2
26.62
2021-08
3
25.87
2021-09
0
26.57
2021-10
1
13.4
2021-11
2
37.66
2021-12
0
40.89
2022-01
2
37.75
2022-02
2
34.42
2022-03
2
36.79
2022-04
0
35.22
2022-05
0
37.22
2022-06
0
36.79
2022-07
2
35.39
2022-08
0
37.6
2022-09
2
36.7
2022-10
2
42.21
2022-11
0
39.36
2022-12
0
41.85
2023-01
0
34.77
2023-02
0
35.66
2023-03
2
41.37
2023-04
2
38.17
2023-05
2
41.87
2023-06
4
45.96
2023-07
2
39.31
2023-08
2
33.01
2023-09
18
31.49
2023-10
2
33.43
2023-11
4
36.94
2023-12
2
34.53
2024-01
0
34.21
2024-02
0
34.57
2024-03
0
34.07
2024-04
2
37.37
2024-05
0
34.78
2024-06
0
33.12
2024-07
4
32.62
2024-08
0
31.39
2024-09
2
36.84
2024-10
0
36.67
2024-11
6
30.96
2024-12
1
26.15
2025-01
0
24.35
2025-02
0
23.19
2025-03
0
25.54
2025-04
0
14.63
2025-05
0
10.86
2025-06
2
51.12
2025-07
0
38.65
2025-08
0
31.25
2025-09
0
24.9
2025-10
0
23.31
2025-11
0
25.93
2025-12
4
29.86
2026-01
0
27.04
2026-02
0
27.07
2026-03
0
26.64
2026-04
2
25.99
2026-05
0
26.41
2026-06
0
27.45
This device (reports/month)Average device in DZE (reports/device/month)
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
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.
Manufacturer compliance record
Date
Type
Outcome
Facility
Citations
2018-08-30
VAI
Voluntary action indicated
Straumann Manufacturing, Inc
2
2017-12-07
VAI
Voluntary action indicated
Jjgc Industria E Comercio De Materials Dentarios Sa