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Unnamed device
Model 02.227.080 · Synthes GmbH · DI 10886982060815
HWC — Screw, Fixation, Bone · Class II · 21 CFR 888.3040
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
2.11
2019-02
0
1.6
2019-03
0
1.65
2019-04
0
2.23
2019-05
0
1.75
2019-06
0
1.81
2019-07
0
2.06
2019-08
0
2.03
2019-09
0
1.75
2019-10
0
1.69
2019-11
0
1.96
2019-12
0
2.52
2020-01
0
2.55
2020-02
0
2.13
2020-03
0
1.9
2020-04
0
1.87
2020-05
0
1.75
2020-06
0
2.06
2020-07
0
2.67
2020-08
0
2.5
2020-09
0
2.44
2020-10
0
2.22
2020-11
0
2.83
2020-12
0
2.48
2021-01
0
1.85
2021-02
0
2.29
2021-03
0
2.59
2021-04
0
2.7
2021-05
0
2.4
2021-06
0
2.2
2021-07
0
2.29
2021-08
0
2.07
2021-09
0
2.36
2021-10
0
2.08
2021-11
0
2.26
2021-12
0
2.35
2022-01
0
2.94
2022-02
0
2.2
2022-03
0
2.01
2022-04
0
1.94
2022-05
0
2.37
2022-06
0
2.22
2022-07
0
2.18
2022-08
0
2.48
2022-09
0
2.88
2022-10
0
3
2022-11
0
2.99
2022-12
0
5.49
2023-01
0
2.72
2023-02
0
2.85
2023-03
0
3.08
2023-04
0
2.76
2023-05
0
3.3
2023-06
0
2.94
2023-07
0
2.28
2023-08
0
2.16
2023-09
0
2.02
2023-10
0
2.14
2023-11
0
1.87
2023-12
0
2.44
2024-01
0
2.76
2024-02
0
1.81
2024-03
0
2.34
2024-04
0
2.12
2024-05
0
2.3
2024-06
0
2.26
2024-07
0
2.46
2024-08
0
2.14
2024-09
0
2.15
2024-10
0
2.19
2024-11
0
2.05
2024-12
0
2.76
2025-01
0
2.2
2025-02
0
2.18
2025-03
0
2.06
2025-04
0
2.54
2025-05
0
2.49
2025-06
0
2.01
2025-07
0
2.14
2025-08
0
2.39
2025-09
0
2.07
2025-10
0
2.47
2025-11
0
2.05
2025-12
0
2.73
2026-01
0
2.06
2026-02
0
2.37
2026-03
0
2.62
2026-04
0
2.17
2026-05
0
2.56
2026-06
0
2.32
This device (reports/month)Average device in HWC (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K080943 — cited as predicate by K111994, K132248, K133451, K133460, K143165, K161616, K161894, K190830, K210146
Lineage extracted from public 510(k) summary text (heuristic).