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RIGIDLOOP
Model 232447 · Medos International Sàrl · DI 10886705024094
MBI — Fastener, Fixation, Nondegradable, Soft Tissue · Class II · 21 CFR 888.3040
UDILibrary device dossier · generated 2026-09-07 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (946)
Caveat (required reading): 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 is a reporting baseline (average device in the same product code), not a risk measure.
Malfunction: 909 · Injury: 37
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
32
4.67
2019-02
2
2.34
2019-03
4
3.13
2019-04
1
3.17
2019-05
3
3.26
2019-06
0
2.82
2019-07
7
3.81
2019-08
6
3.49
2019-09
7
3.35
2019-10
0
3.19
2019-11
12
5.28
2019-12
21
5.45
2020-01
23
5.46
2020-02
3
4.5
2020-03
3
3.98
2020-04
3
5.42
2020-05
15
3.88
2020-06
1
3.71
2020-07
0
3.74
2020-08
3
4.23
2020-09
8
4.05
2020-10
0
4.53
2020-11
12
6.39
2020-12
7
5.41
2021-01
9
4.74
2021-02
4
3.95
2021-03
4
3.83
2021-04
3
3.82
2021-05
5
4.06
2021-06
7
4.11
2021-07
5
4
2021-08
8
4.46
2021-09
5
4.05
2021-10
4
4.44
2021-11
4
4.37
2021-12
6
4.43
2022-01
2
4
2022-02
6
3.37
2022-03
3
3.88
2022-04
2
3.8
2022-05
5
4.06
2022-06
4
3.85
2022-07
5
3.56
2022-08
7
4.39
2022-09
1
3.86
2022-10
4
4.15
2022-11
3
2.87
2022-12
10
3.93
2023-01
2
3.27
2023-02
1
3.2
2023-03
7
3.8
2023-04
13
4.26
2023-05
7
4.67
2023-06
6
4.2
2023-07
10
3.85
2023-08
12
4.49
2023-09
18
4.47
2023-10
11
4.71
2023-11
14
4.63
2023-12
18
5.49
2024-01
17
5.56
2024-02
17
4.93
2024-03
7
4.78
2024-04
8
5.43
2024-05
17
6.48
2024-06
14
7.52
2024-07
12
4.11
2024-08
10
4.21
2024-09
14
5
2024-10
21
4.7
2024-11
14
4.41
2024-12
21
4.25
2025-01
19
5.12
2025-02
13
4.81
2025-03
15
4.57
2025-04
18
4.98
2025-05
22
5.81
2025-06
15
5.47
2025-07
30
5.19
2025-08
22
5.08
2025-09
18
4.29
2025-10
14
4.62
2025-11
26
5.25
2025-12
29
6.07
2026-01
21
5.06
2026-02
14
5.39
2026-03
19
5.98
2026-04
21
5.93
2026-05
18
5.88
2026-06
32
6.16
This device (reports/month)Average device in MBI (reports/device/month)