Model Ti-M07.03S · Auxein Medical Private Limited · DI 08903993536841
HRS — Plate, Fixation, Bone · Class II · 21 CFR 888.3030
UDILibrary device dossier · generated 2026-09-06 · 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 (0)
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.
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
1.94
2019-02
0
1.56
2019-03
0
1.88
2019-04
0
2.36
2019-05
0
1.69
2019-06
0
1.64
2019-07
0
1.68
2019-08
0
1.54
2019-09
0
1.66
2019-10
0
1.53
2019-11
0
1.8
2019-12
0
2
2020-01
0
2.19
2020-02
0
1.28
2020-03
0
1.64
2020-04
0
1.95
2020-05
0
1.79
2020-06
0
1.92
2020-07
0
1.93
2020-08
0
2.34
2020-09
0
2.75
2020-10
0
1.95
2020-11
0
2.34
2020-12
0
2.26
2021-01
0
1.79
2021-02
0
1.94
2021-03
0
2.13
2021-04
0
2.85
2021-05
0
2.64
2021-06
0
2.05
2021-07
0
2.28
2021-08
0
1.87
2021-09
0
2.04
2021-10
0
2.02
2021-11
0
2.05
2021-12
0
2.21
2022-01
0
2.88
2022-02
0
2
2022-03
0
1.65
2022-04
0
2.04
2022-05
0
1.96
2022-06
0
2.35
2022-07
0
2.26
2022-08
0
2.01
2022-09
0
2.39
2022-10
0
3
2022-11
0
2.93
2022-12
0
2.83
2023-01
0
2.51
2023-02
0
2.57
2023-03
0
2.98
2023-04
0
3.11
2023-05
0
4.19
2023-06
0
2.96
2023-07
0
2.23
2023-08
0
2.22
2023-09
0
2.08
2023-10
0
2.45
2023-11
0
2.03
2023-12
0
2.42
2024-01
0
2.06
2024-02
0
1.72
2024-03
0
1.82
2024-04
0
2.09
2024-05
0
1.95
2024-06
0
2.35
2024-07
0
2.23
2024-08
0
2.28
2024-09
0
1.66
2024-10
0
2.32
2024-11
0
1.61
2024-12
0
2.88
2025-01
0
1.62
2025-02
0
1.76
2025-03
0
2.68
2025-04
0
1.82
2025-05
0
2.08
2025-06
0
1.73
2025-07
0
2.09
2025-08
0
2.1
2025-09
0
1.75
2025-10
0
2.08
2025-11
0
1.92
2025-12
0
2.46
2026-01
0
1.7
2026-02
0
2
2026-03
0
3.1
2026-04
0
2.2
2026-05
0
2.03
2026-06
0
1.84
This device (reports/month)Average device in HRS (reports/device/month)