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MatrixNEURO
Model 04.503.145S · Synthes GmbH · DI 10887587018591
GWO — Plate, Cranioplasty, Preformed, Alterable · Class II · 21 CFR 882.5320
GXR — Cover, Burr Hole · Class II · 21 CFR 882.5250
UDILibrary device dossier · generated 2026-09-14 · 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
1.5
2019-02
0
1
2019-03
0
2.71
2019-04
0
1.5
2019-05
0
2
2019-06
0
1.27
2019-07
0
1.7
2019-08
0
2.2
2019-09
0
1.75
2019-10
0
2
2019-11
0
2.5
2019-12
0
8.67
2020-01
0
2.2
2020-02
0
1.74
2020-03
0
2.78
2020-04
0
1.9
2020-05
0
2.38
2020-06
0
2.63
2020-07
0
2.82
2020-08
0
1.88
2020-09
0
4
2020-10
0
2.06
2020-11
0
2.08
2020-12
0
2.6
2021-01
0
1.75
2021-02
0
1.86
2021-03
0
2.57
2021-04
0
4.25
2021-05
0
2
2021-06
0
2.13
2021-07
0
1.18
2021-08
0
2.58
2021-09
0
1.86
2021-10
0
2.79
2021-11
0
1.67
2021-12
0
2.07
2022-01
0
2.5
2022-02
0
5.22
2022-03
0
4
2022-04
0
1.11
2022-05
0
1.55
2022-06
0
6
2022-07
0
1.83
2022-08
0
1.75
2022-09
0
1.33
2022-10
0
1.5
2022-11
0
2.43
2022-12
0
4
2023-01
0
2.2
2023-02
0
2
2023-03
0
4.33
2023-04
0
9.5
2023-05
0
1.4
2023-06
0
7.62
2023-07
0
1.92
2023-08
0
1.71
2023-09
0
2.25
2023-10
0
3.13
2023-11
0
2.8
2023-12
0
1.45
2024-01
0
5
2024-02
0
2.88
2024-03
0
2.5
2024-04
0
2.84
2024-05
0
1.67
2024-06
0
1.86
2024-07
0
1
2024-08
0
1.3
2024-09
0
4.67
2024-10
0
4.42
2024-11
0
3.5
2024-12
0
1.5
2025-01
0
1.78
2025-02
0
1
2025-03
0
1.8
2025-04
0
1.92
2025-05
0
2.71
2025-06
0
2.29
2025-07
0
4
2025-08
0
1.5
2025-09
0
1
2025-10
0
1.3
2025-11
0
1
2025-12
0
3.86
2026-01
0
2
2026-02
0
1.8
2026-03
0
3.33
2026-04
0
8.86
2026-05
0
2.82
2026-06
0
4.57
This device (reports/month)Average device in GWO, GXR (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K123723 — cites (transitively): K022012 (d1), K042365 (d1) — cited as predicate by K173039, K192702
Lineage extracted from public 510(k) summary text (heuristic).