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.
1 linked reportMalfunction 1
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-02
0
2
2019-03
0
2
2019-04
0
1.4
2019-05
0
1
2019-06
0
1
2019-07
0
1.25
2019-08
0
1
2019-09
0
2.5
2019-10
0
1.33
2019-11
0
2
2019-12
0
2
2020-02
0
1
2020-03
0
1
2020-04
0
2.2
2020-05
0
3.7
2020-06
0
4.5
2020-07
0
6.83
2020-08
0
6.25
2020-09
0
7.55
2020-10
0
8.78
2020-11
0
7.16
2020-12
0
9.11
2021-01
0
8.33
2021-02
1
7.13
2021-03
0
8.68
2021-04
0
9.32
2021-05
0
8.84
2021-06
0
5.87
2021-07
0
9.26
2021-08
0
10.23
2021-09
0
14.75
2021-10
0
9.8
2021-11
0
9.94
2021-12
0
14.47
2022-01
0
8.22
2022-02
0
10.15
2022-03
0
14.28
2022-04
0
15
2022-05
0
14.84
2022-06
0
15.35
2022-07
0
12.91
2022-08
0
12.68
2022-09
0
13.84
2022-10
0
13.21
2022-11
0
8.78
2022-12
0
11.75
2023-01
0
11.75
2023-02
0
13.29
2023-03
0
15.32
2023-04
0
17.12
2023-05
0
12.63
2023-06
0
11.04
2023-07
0
11.25
2023-08
0
16.39
2023-09
0
15.16
2023-10
0
15.68
2023-11
0
13
2023-12
0
14.56
2024-01
0
17.56
2024-02
0
20.52
2024-03
0
23.77
2024-04
0
21.62
2024-05
0
23.52
2024-06
0
27.62
2024-07
0
24.27
2024-08
0
19.61
2024-09
0
26.56
2024-10
0
25.44
2024-11
0
13.28
2024-12
0
15.48
2025-01
0
14.21
2025-02
0
8.03
2025-03
0
10.06
2025-04
0
11.1
2025-05
0
8.34
2025-06
0
8.78
2025-07
0
9.11
2025-08
0
12.18
2025-09
0
7.21
2025-10
0
9.89
2025-11
0
11.28
2025-12
0
20.43
2026-01
0
16.39
2026-02
0
8.64
2026-03
0
12.37
2026-04
0
17.42
2026-05
0
15.33
2026-06
0
12.69
This device (reports/month)Average device in FET (reports/device/month)
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2021-02-27
1643264-2021-00825
Malfunction
Available
catalog number
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