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
3.57
2019-02
0
2.59
2019-03
0
2.8
2019-04
0
2.58
2019-05
0
2.7
2019-06
0
2.57
2019-07
0
2.85
2019-08
0
2.82
2019-09
0
3.32
2019-10
0
2.62
2019-11
0
2.96
2019-12
0
3.15
2020-01
0
3.35
2020-02
0
2.45
2020-03
0
2.97
2020-04
0
3.61
2020-05
0
2.83
2020-06
0
3.12
2020-07
0
3.8
2020-08
0
3.75
2020-09
0
3.61
2020-10
0
4.35
2020-11
0
4.29
2020-12
0
4.16
2021-01
0
4.55
2021-02
0
4.14
2021-03
0
3.81
2021-04
0
4.45
2021-05
0
3.67
2021-06
0
3.44
2021-07
0
3.43
2021-08
0
3.69
2021-09
0
3.67
2021-10
0
3.54
2021-11
0
4.01
2021-12
0
3.45
2022-01
0
3.57
2022-02
0
3.78
2022-03
0
3.76
2022-04
0
3.79
2022-05
0
4.23
2022-06
0
3.1
2022-07
0
3.17
2022-08
0
3.74
2022-09
0
3.44
2022-10
0
3.96
2022-11
0
4.78
2022-12
0
4.69
2023-01
0
5.49
2023-02
0
4.75
2023-03
0
5.3
2023-04
0
5.17
2023-05
0
5.29
2023-06
0
5.69
2023-07
0
5.51
2023-08
0
5.71
2023-09
0
4.49
2023-10
0
5.04
2023-11
0
4.23
2023-12
0
5.34
2024-01
0
4.28
2024-02
0
5.42
2024-03
0
7.85
2024-04
0
12.78
2024-05
0
11.81
2024-06
0
12.03
2024-07
0
12.19
2024-08
0
7.27
2024-09
0
6.69
2024-10
0
5.11
2024-11
0
4.95
2024-12
0
4.23
2025-01
0
4.12
2025-02
0
4.49
2025-03
0
5.09
2025-04
0
3.98
2025-05
0
4.18
2025-06
0
4.26
2025-07
0
3.77
2025-08
0
3.7
2025-09
0
3.49
2025-10
2
3.59
2025-11
0
4.62
2025-12
0
4.9
2026-01
0
4.6
2026-02
0
5.29
2026-03
0
4.45
2026-04
0
4.4
2026-05
0
4.89
2026-06
0
5.1
This device (reports/month)Average device in GAT, LXH, MAI, NBH (reports/device/month)
Failure-mode summaryAI-generated
2 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2025-10-15
1219602-2025-02560
Injury
Available
catalog number
Showing the most recent 1 of 2 linked reports.
Regulatory clearances
None linked.
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