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Unnamed device
Model 04.045.036S · Synthes GmbH · DI 10886982294401
HSB — Rod, Fixation, Intramedullary And Accessories · Class II · 21 CFR 888.3020
HWC — Screw, Fixation, Bone · Class II · 21 CFR 888.3040
JDS — Nail, Fixation, Bone · Class II · 21 CFR 888.3030
UDILibrary device dossier · generated 2026-09-16 · 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 (2)
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.
Injury: 1 · Malfunction: 1
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
1.95
2019-02
0
1.55
2019-03
0
1.59
2019-04
0
1.82
2019-05
0
1.63
2019-06
0
1.72
2019-07
0
1.91
2019-08
0
1.94
2019-09
0
1.58
2019-10
0
1.64
2019-11
0
1.89
2019-12
0
2.13
2020-01
0
2.23
2020-02
0
1.92
2020-03
0
1.73
2020-04
0
1.91
2020-05
0
1.75
2020-06
0
2.11
2020-07
0
2.45
2020-08
0
2.67
2020-09
0
2.33
2020-10
0
2.31
2020-11
0
2.96
2020-12
0
2.81
2021-01
0
2.25
2021-02
0
2.58
2021-03
0
2.85
2021-04
0
3.02
2021-05
0
3.15
2021-06
0
2.58
2021-07
0
2.33
2021-08
0
2.19
2021-09
0
2.27
2021-10
0
1.93
2021-11
0
2.66
2021-12
0
2.34
2022-01
0
2.87
2022-02
0
2.16
2022-03
0
2.11
2022-04
0
2.06
2022-05
0
2.22
2022-06
0
2.23
2022-07
0
2.03
2022-08
0
2.28
2022-09
0
2.8
2022-10
0
2.81
2022-11
0
2.87
2022-12
0
3.95
2023-01
0
2.58
2023-02
0
2.68
2023-03
0
3.04
2023-04
0
2.64
2023-05
0
3.15
2023-06
0
2.88
2023-07
0
2.19
2023-08
0
2
2023-09
0
1.81
2023-10
1
1.84
2023-11
0
1.73
2023-12
0
2.12
2024-01
0
2.39
2024-02
0
1.71
2024-03
1
2.08
2024-04
0
1.88
2024-05
0
2.11
2024-06
0
2.07
2024-07
0
1.96
2024-08
0
2.03
2024-09
0
2.17
2024-10
0
2.01
2024-11
0
1.97
2024-12
0
2.3
2025-01
0
2.09
2025-02
0
1.99
2025-03
0
1.91
2025-04
0
2.41
2025-05
0
2.15
2025-06
0
1.78
2025-07
0
1.99
2025-08
0
2.15
2025-09
0
1.91
2025-10
0
2.07
2025-11
0
2.01
2025-12
0
2.41
2026-01
0
2.03
2026-02
0
2.09
2026-03
0
2.3
2026-04
0
1.97
2026-05
0
2.26
2026-06
0
2.09
This device (reports/month)Average device in HSB, HWC, JDS (reports/device/month)