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.
2 linked reportsInjury 2
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
2.03
2019-02
0
2.07
2019-03
0
1.68
2019-04
0
2.01
2019-05
0
1.83
2019-06
0
2.19
2019-07
0
2.04
2019-08
0
2.24
2019-09
0
2.01
2019-10
0
2.44
2019-11
0
3.01
2019-12
0
2.42
2020-01
0
2.39
2020-02
0
2.82
2020-03
0
2.28
2020-04
0
2.21
2020-05
0
1.83
2020-06
0
2.09
2020-07
0
2.66
2020-08
0
2.72
2020-09
0
2.23
2020-10
0
2.94
2020-11
0
2.86
2020-12
0
2.95
2021-01
0
2.47
2021-02
0
2.45
2021-03
0
2.59
2021-04
0
2.45
2021-05
0
2.36
2021-06
0
2.18
2021-07
0
2.24
2021-08
0
1.88
2021-09
0
2.33
2021-10
0
1.96
2021-11
0
2.31
2021-12
0
2.33
2022-01
0
2.03
2022-02
0
2.38
2022-03
0
2.05
2022-04
0
2.1
2022-05
0
2.33
2022-06
0
2.03
2022-07
0
2.06
2022-08
0
2.1
2022-09
0
2.28
2022-10
0
2.2
2022-11
0
2.24
2022-12
0
1.9
2023-01
0
2.09
2023-02
0
2.23
2023-03
0
2.23
2023-04
0
2.26
2023-05
0
2.41
2023-06
0
2.26
2023-07
0
2
2023-08
0
1.71
2023-09
0
1.76
2023-10
0
1.63
2023-11
0
1.68
2023-12
0
1.7
2024-01
0
1.57
2024-02
0
1.74
2024-03
0
1.78
2024-04
0
1.64
2024-05
0
1.91
2024-06
0
1.98
2024-07
0
1.85
2024-08
0
2.31
2024-09
0
2
2024-10
0
1.99
2024-11
0
2
2024-12
0
2.09
2025-01
0
2.32
2025-02
0
1.83
2025-03
0
1.86
2025-04
0
1.66
2025-05
0
1.71
2025-06
2
1.81
2025-07
0
1.62
2025-08
0
1.63
2025-09
0
1.64
2025-10
0
1.43
2025-11
0
1.7
2025-12
0
1.66
2026-01
0
1.55
2026-02
0
1.53
2026-03
0
1.99
2026-04
0
1.75
2026-05
0
1.71
2026-06
0
1.7
This device (reports/month)Average device in JWH (reports/device/month)
Failure-mode summaryAI-generated
2 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
2025-01-27
NAI
No action indicated
Integrity Orthopaedics Inc
0
2023-05-03
NAI
No action indicated
CARTIHEAL, LTD
0
2021-12-09
VAI
Voluntary action indicated
Smith & Nephew, Inc.
1
2021-12-09
VAI
Voluntary action indicated
Smith & Nephew, Inc.
1
2021-10-26
NAI
No action indicated
Smith & Nephew Inc.
0
2021-10-26
NAI
No action indicated
Smith & Nephew Inc.
0
2020-02-06
VAI
Voluntary action indicated
Blue Belt Technologies, Inc
6
2019-10-25
NAI
No action indicated
Tusker Medical, Inc.
0
2019-10-08
VAI
Voluntary action indicated
Tusker Medical, Inc.
3
2018-03-30
NAI
No action indicated
Ascension Orthopedics, Inc
0
2018-02-02
NAI
No action indicated
Smith & Nephew, Inc.
0
2018-02-02
NAI
No action indicated
Smith & Nephew, Inc.
0
2018-01-30
NAI
No action indicated
Smith & Nephew
0
2017-08-21
NAI
No action indicated
Smith & Nephew, Inc. Advanced Surgical Devices Division