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BonOs R Genta 1x40
Model 01-0217 · OSARTIS GmbH · DI 04260056885679
LOD — Bone Cement · Class II · 21 CFR 888.3027
MBB — Bone Cement, Antibiotic · Class II · 21 CFR 888.3027
UDILibrary device dossier · generated 2026-09-08 · 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
5.15
2019-02
0
6.5
2019-03
0
3.86
2019-04
0
6.82
2019-05
0
4.46
2019-06
0
6.95
2019-07
0
7.15
2019-08
0
15.71
2019-09
0
15.88
2019-10
0
29.33
2019-11
0
38.28
2019-12
0
27.82
2020-01
0
21.91
2020-02
0
12.06
2020-03
0
11
2020-04
0
6.62
2020-05
0
6.43
2020-06
0
9.29
2020-07
0
5.7
2020-08
0
5.45
2020-09
0
6.17
2020-10
0
3.82
2020-11
0
20.25
2020-12
0
7.19
2021-01
0
5.61
2021-02
0
8.4
2021-03
0
10.05
2021-04
0
12.86
2021-05
0
7.2
2021-06
0
7.63
2021-07
0
6.65
2021-08
0
4.8
2021-09
0
3.73
2021-10
0
4.12
2021-11
0
4.33
2021-12
0
4.55
2022-01
0
4.17
2022-02
0
3.5
2022-03
0
6.36
2022-04
0
3.54
2022-05
0
3.24
2022-06
0
2.72
2022-07
0
4.68
2022-08
0
2.59
2022-09
0
2.14
2022-10
0
3.6
2022-11
0
3.5
2022-12
0
2.75
2023-01
0
2.36
2023-02
0
2.38
2023-03
0
5.07
2023-04
0
2.5
2023-05
0
2.42
2023-06
0
3.43
2023-07
0
3.54
2023-08
0
8.06
2023-09
0
2.5
2023-10
0
2.25
2023-11
0
2.14
2023-12
0
3.67
2024-01
0
4.64
2024-02
0
4.91
2024-03
0
2.64
2024-04
0
1.86
2024-05
0
4.38
2024-06
0
3.92
2024-07
0
3.5
2024-08
0
3.67
2024-09
0
2.79
2024-10
0
3.93
2024-11
0
3.24
2024-12
0
3.58
2025-01
0
2.38
2025-02
0
3.14
2025-03
0
3.46
2025-04
0
2
2025-05
0
3.05
2025-06
0
2.13
2025-07
0
2.56
2025-08
0
1.8
2025-09
0
1.4
2025-10
0
2.92
2025-11
0
2.13
2025-12
0
2.25
2026-01
0
3.89
2026-02
0
2.14
2026-03
0
2.5
2026-04
0
2
2026-05
0
2.36
2026-06
0
2.38
This device (reports/month)Average device in LOD, MBB (reports/device/month)