Unnamed device
Model 04.003.032 · Synthes GmbH · DI 10886982081674
HSB — Rod, Fixation, Intramedullary And Accessories · Class II · 21 CFR 888.3020
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 (1)
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
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.41 |
| 2019-02 | 0 | 1.44 |
| 2019-03 | 0 | 1.62 |
| 2019-04 | 0 | 1.4 |
| 2019-05 | 0 | 1.35 |
| 2019-06 | 0 | 1.56 |
| 2019-07 | 0 | 1.47 |
| 2019-08 | 0 | 1.71 |
| 2019-09 | 0 | 1.4 |
| 2019-10 | 0 | 1.44 |
| 2019-11 | 0 | 1.67 |
| 2019-12 | 0 | 1.5 |
| 2020-01 | 0 | 1.53 |
| 2020-02 | 0 | 1.4 |
| 2020-03 | 0 | 1.43 |
| 2020-04 | 0 | 1.96 |
| 2020-05 | 0 | 1.84 |
| 2020-06 | 0 | 2.15 |
| 2020-07 | 0 | 2.29 |
| 2020-08 | 0 | 3.06 |
| 2020-09 | 0 | 2.11 |
| 2020-10 | 0 | 2.5 |
| 2020-11 | 0 | 3.28 |
| 2020-12 | 0 | 3.43 |
| 2021-01 | 0 | 3.12 |
| 2021-02 | 0 | 3.06 |
| 2021-03 | 0 | 3.26 |
| 2021-04 | 0 | 3.44 |
| 2021-05 | 0 | 4.35 |
| 2021-06 | 0 | 3.12 |
| 2021-07 | 0 | 2.45 |
| 2021-08 | 0 | 2.05 |
| 2021-09 | 0 | 2.24 |
| 2021-10 | 0 | 1.74 |
| 2021-11 | 0 | 3.41 |
| 2021-12 | 0 | 2.36 |
| 2022-01 | 0 | 2.92 |
| 2022-02 | 0 | 2.06 |
| 2022-03 | 0 | 2.25 |
| 2022-04 | 0 | 2.35 |
| 2022-05 | 0 | 2.06 |
| 2022-06 | 0 | 2.2 |
| 2022-07 | 1 | 1.78 |
| 2022-08 | 0 | 1.88 |
| 2022-09 | 0 | 2.28 |
| 2022-10 | 0 | 2.35 |
| 2022-11 | 0 | 2.23 |
| 2022-12 | 0 | 2.13 |
| 2023-01 | 0 | 2.14 |
| 2023-02 | 0 | 2.19 |
| 2023-03 | 0 | 2.56 |
| 2023-04 | 0 | 2.33 |
| 2023-05 | 0 | 2.56 |
| 2023-06 | 0 | 2.56 |
| 2023-07 | 0 | 1.93 |
| 2023-08 | 0 | 1.68 |
| 2023-09 | 0 | 1.41 |
| 2023-10 | 0 | 1.43 |
| 2023-11 | 0 | 1.5 |
| 2023-12 | 0 | 1.51 |
| 2024-01 | 0 | 1.56 |
| 2024-02 | 0 | 1.42 |
| 2024-03 | 0 | 1.7 |
| 2024-04 | 0 | 1.4 |
| 2024-05 | 0 | 1.7 |
| 2024-06 | 0 | 1.71 |
| 2024-07 | 0 | 1.43 |
| 2024-08 | 0 | 1.92 |
| 2024-09 | 0 | 2.2 |
| 2024-10 | 0 | 1.64 |
| 2024-11 | 0 | 1.51 |
| 2024-12 | 0 | 1.62 |
| 2025-01 | 0 | 1.66 |
| 2025-02 | 0 | 1.51 |
| 2025-03 | 0 | 1.53 |
| 2025-04 | 0 | 1.54 |
| 2025-05 | 0 | 1.51 |
| 2025-06 | 0 | 1.43 |
| 2025-07 | 0 | 1.54 |
| 2025-08 | 0 | 1.48 |
| 2025-09 | 0 | 1.38 |
| 2025-10 | 0 | 1.61 |
| 2025-11 | 0 | 1.75 |
| 2025-12 | 0 | 1.77 |
| 2026-01 | 0 | 1.85 |
| 2026-02 | 0 | 1.47 |
| 2026-03 | 0 | 1.77 |
| 2026-04 | 0 | 1.6 |
| 2026-05 | 0 | 1.67 |
| 2026-06 | 0 | 1.59 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K040336 — cited as predicate by K111891, K172157, K172830, K182783, K192003, K203811, K233150
K172157 — cites (transitively): K040336 (d1), K040462 (d1), K070843 (d1) — cited as predicate by K201336, K220659
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Synthes GmbH
- Warning Letter 2012-02-16 Synthes, Inc.
- NAI 2017-08-08 Synthes GmbH · 0 citations
- NAI 2017-01-18 Synthes (USA), LLC · 0 citations
- VAI 2015-05-08 Synthes (USA), LLC · 2 citations
- VAI 2013-11-13 Synthes, Inc. · 1 citations
- NAI 2013-05-16 Synthes, Inc. · 0 citations
- VAI 2012-10-19 Synthes, Inc. · 1 citations
- NAI 2012-02-01 Synthes (USA), LLC · 0 citations
- OAI 2011-09-15 Synthes, Inc. · 10 citations