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TRUESPAN ORTHOCORD
Model 228162 · Medos International Sàrl · DI 10886705026050
MBI — Fastener, Fixation, Nondegradable, Soft Tissue · Class II · 21 CFR 888.3040
UDILibrary device dossier · generated 2026-09-12 · 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 (729)
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: 724 · Injury: 5
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
4.67
2019-02
0
2.34
2019-03
0
3.13
2019-04
0
3.17
2019-05
0
3.26
2019-06
0
2.82
2019-07
0
3.81
2019-08
0
3.49
2019-09
0
3.35
2019-10
0
3.19
2019-11
0
5.28
2019-12
2
5.45
2020-01
3
5.46
2020-02
0
4.5
2020-03
0
3.98
2020-04
0
5.42
2020-05
0
3.88
2020-06
3
3.71
2020-07
0
3.74
2020-08
9
4.23
2020-09
9
4.05
2020-10
9
4.53
2020-11
31
6.39
2020-12
15
5.41
2021-01
0
4.74
2021-02
3
3.95
2021-03
1
3.83
2021-04
1
3.82
2021-05
2
4.06
2021-06
1
4.11
2021-07
6
4
2021-08
6
4.46
2021-09
10
4.05
2021-10
13
4.44
2021-11
3
4.37
2021-12
9
4.43
2022-01
4
4
2022-02
5
3.37
2022-03
4
3.88
2022-04
3
3.8
2022-05
5
4.06
2022-06
4
3.85
2022-07
8
3.56
2022-08
7
4.39
2022-09
6
3.86
2022-10
6
4.15
2022-11
4
2.87
2022-12
6
3.93
2023-01
2
3.27
2023-02
4
3.2
2023-03
3
3.8
2023-04
7
4.26
2023-05
1
4.67
2023-06
5
4.2
2023-07
2
3.85
2023-08
8
4.49
2023-09
12
4.47
2023-10
6
4.71
2023-11
16
4.63
2023-12
13
5.49
2024-01
8
5.56
2024-02
9
4.93
2024-03
18
4.78
2024-04
4
5.43
2024-05
14
6.48
2024-06
9
7.52
2024-07
2
4.11
2024-08
9
4.21
2024-09
16
5
2024-10
29
4.7
2024-11
12
4.41
2024-12
14
4.25
2025-01
12
5.12
2025-02
12
4.81
2025-03
6
4.57
2025-04
26
4.98
2025-05
19
5.81
2025-06
25
5.47
2025-07
30
5.19
2025-08
11
5.08
2025-09
12
4.29
2025-10
24
4.62
2025-11
18
5.25
2025-12
10
6.07
2026-01
12
5.06
2026-02
17
5.39
2026-03
11
5.98
2026-04
15
5.93
2026-05
18
5.88
2026-06
30
6.16
This device (reports/month)Average device in MBI (reports/device/month)