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BonOs R 1x40
Model 01-0117 · OSARTIS GmbH · DI 04260056885624
LOD — Bone Cement · Class II · 21 CFR 888.3027
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
4.71
2019-02
0
5.36
2019-03
0
3.38
2019-04
0
5.83
2019-05
0
3.67
2019-06
0
6.08
2019-07
0
6.23
2019-08
0
13.93
2019-09
0
14.91
2019-10
0
23.47
2019-11
0
34.33
2019-12
0
24.64
2020-01
0
19.47
2020-02
0
10.83
2020-03
0
9.93
2020-04
0
6.62
2020-05
0
5.7
2020-06
0
9.11
2020-07
0
5.53
2020-08
0
4.22
2020-09
0
6.07
2020-10
0
3.82
2020-11
0
18.75
2020-12
0
6.3
2021-01
0
5.33
2021-02
0
7.7
2021-03
0
8.15
2021-04
0
11.47
2021-05
0
6.23
2021-06
0
7.08
2021-07
0
5.92
2021-08
0
4.62
2021-09
0
3.5
2021-10
0
4.13
2021-11
0
3.67
2021-12
0
4
2022-01
0
3.69
2022-02
0
3.17
2022-03
0
6.11
2022-04
0
3.33
2022-05
0
3.17
2022-06
0
2.92
2022-07
0
4.58
2022-08
0
2.5
2022-09
0
2.11
2022-10
0
3.15
2022-11
0
3.3
2022-12
0
2.83
2023-01
0
2.64
2023-02
0
2.5
2023-03
0
4.7
2023-04
0
2.44
2023-05
0
2.42
2023-06
0
3.11
2023-07
0
4.1
2023-08
0
6.64
2023-09
0
2.11
2023-10
0
2.2
2023-11
0
2.11
2023-12
0
4
2024-01
0
4.14
2024-02
0
4.75
2024-03
0
2.6
2024-04
0
2
2024-05
0
4.17
2024-06
0
4.22
2024-07
0
2.6
2024-08
0
3.14
2024-09
0
2.8
2024-10
0
3.91
2024-11
0
2.92
2024-12
0
3.25
2025-01
0
2.44
2025-02
0
3.25
2025-03
0
3.22
2025-04
0
2
2025-05
0
2.79
2025-06
0
2.2
2025-07
0
2.83
2025-08
0
1.5
2025-09
0
1.67
2025-10
0
2.63
2025-11
0
2
2025-12
0
2.2
2026-01
0
3.43
2026-02
0
2
2026-03
0
2.57
2026-04
0
2
2026-05
0
2.57
2026-06
0
2.4
This device (reports/month)Average device in LOD (reports/device/month)