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3.5mm x 18mm Cannulated Headed Screw
Model CH3518 · CONVENTUS ORTHOPAEDICS, INC. · DI 00814289020464
HRS — Plate, Fixation, Bone · Class II · 21 CFR 888.3030
JDS — Nail, Fixation, Bone · Class II · 21 CFR 888.3030
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 (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
1.91
2019-02
0
1.58
2019-03
0
1.74
2019-04
0
2.15
2019-05
0
1.75
2019-06
0
1.66
2019-07
0
1.76
2019-08
0
1.57
2019-09
0
1.55
2019-10
0
1.61
2019-11
0
1.88
2019-12
0
2.01
2020-01
0
2.11
2020-02
0
1.29
2020-03
0
1.64
2020-04
0
1.94
2020-05
0
1.72
2020-06
0
1.97
2020-07
0
1.91
2020-08
0
2.29
2020-09
0
2.75
2020-10
0
1.95
2020-11
0
2.29
2020-12
0
2.16
2021-01
0
1.77
2021-02
0
1.92
2021-03
0
2.11
2021-04
0
2.79
2021-05
0
2.54
2021-06
0
2.02
2021-07
0
2.19
2021-08
0
2.18
2021-09
0
2.02
2021-10
0
2.01
2021-11
0
2
2021-12
0
2.2
2022-01
0
2.7
2022-02
0
2.14
2022-03
0
1.71
2022-04
0
1.95
2022-05
0
1.93
2022-06
0
2.37
2022-07
0
2.25
2022-08
0
2.08
2022-09
0
2.8
2022-10
0
3.01
2022-11
0
3.11
2022-12
0
2.9
2023-01
0
2.68
2023-02
0
2.8
2023-03
0
3.31
2023-04
0
3.11
2023-05
0
4.25
2023-06
0
3.13
2023-07
0
2.33
2023-08
0
2.2
2023-09
0
2.01
2023-10
0
2.3
2023-11
0
1.93
2023-12
0
2.32
2024-01
0
2.21
2024-02
0
1.75
2024-03
0
1.87
2024-04
0
2.06
2024-05
0
1.91
2024-06
0
2.34
2024-07
0
2.09
2024-08
0
2.19
2024-09
0
1.78
2024-10
0
2.33
2024-11
0
1.88
2024-12
0
2.79
2025-01
0
1.91
2025-02
0
2.02
2025-03
0
2.66
2025-04
0
2.49
2025-05
0
2.27
2025-06
0
1.78
2025-07
0
2.21
2025-08
0
2.18
2025-09
0
1.95
2025-10
0
2.2
2025-11
0
2.14
2025-12
0
2.72
2026-01
0
1.89
2026-02
0
2.17
2026-03
0
3
2026-04
0
2.17
2026-05
0
2.12
2026-06
0
1.94
This device (reports/month)Average device in HRS, JDS (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — CONVENTUS ORTHOPAEDICS, INC.
NAI 2016-11-30 Conventus Orthopaedics Inc · 0 citations
NAI 2013-09-25 Conventus Orthopaedics Inc · 0 citations