Print-ready dossier — use your browser's print dialog to save as PDF.
TRUESPAN ORTHOCORD
Model 228151 · Medos International Sàrl · DI 10886705026012
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 (2496)
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: 2413 · Injury: 83
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
42
4.67
2019-02
9
2.34
2019-03
10
3.13
2019-04
23
3.17
2019-05
46
3.26
2019-06
17
2.82
2019-07
30
3.81
2019-08
34
3.49
2019-09
19
3.35
2019-10
35
3.19
2019-11
82
5.28
2019-12
66
5.45
2020-01
51
5.46
2020-02
42
4.5
2020-03
36
3.98
2020-04
27
5.42
2020-05
6
3.88
2020-06
31
3.71
2020-07
24
3.74
2020-08
7
4.23
2020-09
28
4.05
2020-10
58
4.53
2020-11
45
6.39
2020-12
48
5.41
2021-01
21
4.74
2021-02
16
3.95
2021-03
33
3.83
2021-04
18
3.82
2021-05
13
4.06
2021-06
28
4.11
2021-07
27
4
2021-08
16
4.46
2021-09
24
4.05
2021-10
7
4.44
2021-11
27
4.37
2021-12
14
4.43
2022-01
18
4
2022-02
13
3.37
2022-03
28
3.88
2022-04
8
3.8
2022-05
6
4.06
2022-06
28
3.85
2022-07
14
3.56
2022-08
13
4.39
2022-09
13
3.86
2022-10
30
4.15
2022-11
16
2.87
2022-12
22
3.93
2023-01
16
3.27
2023-02
8
3.2
2023-03
16
3.8
2023-04
17
4.26
2023-05
25
4.67
2023-06
23
4.2
2023-07
27
3.85
2023-08
24
4.49
2023-09
37
4.47
2023-10
32
4.71
2023-11
26
4.63
2023-12
43
5.49
2024-01
25
5.56
2024-02
21
4.93
2024-03
30
4.78
2024-04
30
5.43
2024-05
37
6.48
2024-06
44
7.52
2024-07
18
4.11
2024-08
34
4.21
2024-09
41
5
2024-10
27
4.7
2024-11
40
4.41
2024-12
30
4.25
2025-01
36
5.12
2025-02
50
4.81
2025-03
15
4.57
2025-04
24
4.98
2025-05
26
5.81
2025-06
32
5.47
2025-07
21
5.19
2025-08
17
5.08
2025-09
15
4.29
2025-10
4
4.62
2025-11
39
5.25
2025-12
36
6.07
2026-01
25
5.06
2026-02
40
5.39
2026-03
62
5.98
2026-04
33
5.93
2026-05
46
5.88
2026-06
35
6.16
This device (reports/month)Average device in MBI (reports/device/month)