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TRUESPAN ORTHOCORD
Model 228152 · Medos International Sàrl · DI 10886705026029
MBI — Fastener, Fixation, Nondegradable, Soft Tissue · Class II · 21 CFR 888.3040
UDILibrary device dossier · generated 2026-09-13 · 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 (2188)
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: 2167 · Injury: 21
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
2
4.67
2019-02
7
2.34
2019-03
10
3.13
2019-04
14
3.17
2019-05
9
3.26
2019-06
13
2.82
2019-07
6
3.81
2019-08
22
3.49
2019-09
22
3.35
2019-10
17
3.19
2019-11
32
5.28
2019-12
32
5.45
2020-01
24
5.46
2020-02
21
4.5
2020-03
27
3.98
2020-04
15
5.42
2020-05
18
3.88
2020-06
12
3.71
2020-07
12
3.74
2020-08
24
4.23
2020-09
21
4.05
2020-10
18
4.53
2020-11
19
6.39
2020-12
40
5.41
2021-01
9
4.74
2021-02
17
3.95
2021-03
5
3.83
2021-04
9
3.82
2021-05
8
4.06
2021-06
19
4.11
2021-07
5
4
2021-08
9
4.46
2021-09
14
4.05
2021-10
7
4.44
2021-11
11
4.37
2021-12
11
4.43
2022-01
8
4
2022-02
3
3.37
2022-03
17
3.88
2022-04
5
3.8
2022-05
20
4.06
2022-06
17
3.85
2022-07
16
3.56
2022-08
15
4.39
2022-09
23
3.86
2022-10
16
4.15
2022-11
10
2.87
2022-12
17
3.93
2023-01
9
3.27
2023-02
7
3.2
2023-03
21
3.8
2023-04
21
4.26
2023-05
24
4.67
2023-06
19
4.2
2023-07
37
3.85
2023-08
62
4.49
2023-09
34
4.47
2023-10
51
4.71
2023-11
67
4.63
2023-12
52
5.49
2024-01
27
5.56
2024-02
26
4.93
2024-03
26
4.78
2024-04
43
5.43
2024-05
21
6.48
2024-06
27
7.52
2024-07
52
4.11
2024-08
19
4.21
2024-09
21
5
2024-10
40
4.7
2024-11
14
4.41
2024-12
19
4.25
2025-01
33
5.12
2025-02
15
4.81
2025-03
45
4.57
2025-04
36
4.98
2025-05
42
5.81
2025-06
62
5.47
2025-07
71
5.19
2025-08
40
5.08
2025-09
51
4.29
2025-10
33
4.62
2025-11
18
5.25
2025-12
50
6.07
2026-01
45
5.06
2026-02
46
5.39
2026-03
40
5.98
2026-04
45
5.93
2026-05
22
5.88
2026-06
27
6.16
This device (reports/month)Average device in MBI (reports/device/month)