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.
4 linked reportsMalfunction 4
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
2.33
2019-02
0
1.53
2019-03
0
2.33
2019-04
0
2.14
2019-05
0
2.28
2019-06
0
2.4
2019-07
0
1.92
2019-08
0
2.5
2019-09
0
3.42
2019-10
0
2.26
2019-11
0
1.86
2019-12
0
2.2
2020-01
0
3.07
2020-02
4
2.29
2020-03
0
2.4
2020-04
0
1.75
2020-05
0
1.67
2020-06
0
2.95
2020-07
0
2.33
2020-08
0
2.7
2020-09
0
2.59
2020-10
0
2.84
2020-11
0
2.83
2020-12
0
2.62
2021-01
0
3.19
2021-02
0
2.67
2021-03
0
2.87
2021-04
0
3.2
2021-05
0
2.67
2021-06
0
2.46
2021-07
0
2.4
2021-08
0
2.05
2021-09
0
2.9
2021-10
0
2.62
2021-11
0
2.63
2021-12
0
2
2022-01
0
2.63
2022-02
0
1.65
2022-03
0
2.41
2022-04
0
2.59
2022-05
0
2.73
2022-06
0
1.89
2022-07
0
2.29
2022-08
0
2.4
2022-09
0
2.17
2022-10
0
2.47
2022-11
0
2.32
2022-12
0
3.59
2023-01
0
2.25
2023-02
0
3.1
2023-03
0
2.81
2023-04
0
2
2023-05
0
4.46
2023-06
0
3.52
2023-07
0
3.38
2023-08
0
2.3
2023-09
0
3.46
2023-10
0
2.64
2023-11
0
3.76
2023-12
0
3.56
2024-01
0
2.48
2024-02
0
2.73
2024-03
0
2.95
2024-04
0
2.32
2024-05
0
4.15
2024-06
0
5.53
2024-07
0
3.14
2024-08
0
2.3
2024-09
0
2.76
2024-10
0
2.61
2024-11
0
2.5
2024-12
0
2.7
2025-01
0
3.35
2025-02
0
3.62
2025-03
0
3.11
2025-04
0
3
2025-05
0
3
2025-06
0
2.44
2025-07
0
2.88
2025-08
0
2.84
2025-09
0
1.89
2025-10
0
3
2025-11
0
2.94
2025-12
0
3.71
2026-01
0
2.45
2026-02
0
3.21
2026-03
0
2.39
2026-04
0
2.57
2026-05
0
3.8
2026-06
0
2.86
This device (reports/month)Average device in NBH (reports/device/month)
Failure-mode summaryAI-generated
4 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2020-02-18
1219602-2020-00232
Malfunction
Available
catalog number
2020-02-18
1219602-2020-00231
Malfunction
Available
catalog number
Showing the most recent 2 of 4 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