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MatrixNEURO
Model 04.503.097 · Synthes GmbH · DI 10887587018270
GWO — Plate, Cranioplasty, Preformed, Alterable · Class II · 21 CFR 882.5320
GXR — Cover, Burr Hole · Class II · 21 CFR 882.5250
JEY — Plate, Bone · Class II · 21 CFR 872.4760
UDILibrary device dossier · generated 2026-09-07 · 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.
Malfunction: 2
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
1.44
2019-02
0
1.29
2019-03
0
2.49
2019-04
0
2.57
2019-05
0
3.11
2019-06
0
1.34
2019-07
0
1.74
2019-08
0
2.08
2019-09
0
1.93
2019-10
0
2.5
2019-11
0
1.8
2019-12
0
3.17
2020-01
0
2.42
2020-02
0
1.79
2020-03
0
2.31
2020-04
0
2.04
2020-05
0
2.34
2020-06
0
2.32
2020-07
0
2.41
2020-08
0
2.11
2020-09
0
2.73
2020-10
0
2.14
2020-11
0
1.85
2020-12
0
2.13
2021-01
0
2
2021-02
0
1.43
2021-03
0
2.25
2021-04
0
3.65
2021-05
0
3.21
2021-06
0
2
2021-07
0
1.25
2021-08
0
2.96
2021-09
0
1.65
2021-10
0
2.42
2021-11
0
1.85
2021-12
0
3
2022-01
0
2.26
2022-02
0
3.52
2022-03
0
3.65
2022-04
0
1.87
2022-05
0
1.67
2022-06
0
3.67
2022-07
0
2.08
2022-08
0
2.04
2022-09
0
1.43
2022-10
0
5.85
2022-11
0
2.33
2022-12
0
3.65
2023-01
0
2.53
2023-02
0
3.09
2023-03
0
3.29
2023-04
0
5.06
2023-05
0
2.31
2023-06
0
5.52
2023-07
0
2.97
2023-08
0
2.64
2023-09
0
2.45
2023-10
0
2.24
2023-11
0
2.7
2023-12
0
1.83
2024-01
0
3.64
2024-02
0
2.74
2024-03
0
2.32
2024-04
0
2.73
2024-05
0
2.1
2024-06
0
1.84
2024-07
0
1.38
2024-08
0
1.45
2024-09
0
2.5
2024-10
0
3
2024-11
0
3.13
2024-12
0
1.63
2025-01
0
1.69
2025-02
0
1.27
2025-03
0
1.93
2025-04
0
1.91
2025-05
0
2.41
2025-06
0
2.11
2025-07
0
4.06
2025-08
0
2.33
2025-09
0
1.55
2025-10
0
1.72
2025-11
0
1.35
2025-12
0
4.25
2026-01
0
1.7
2026-02
0
2.25
2026-03
0
1.43
2026-04
2
4.43
2026-05
0
2.34
2026-06
0
3.87
This device (reports/month)Average device in GWO, GXR, JEY (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K042365 — cited as predicate by K123723, K173039, K192655, K192702
K123723 — cites (transitively): K022012 (d1), K042365 (d1) — cited as predicate by K173039, K192702
Lineage extracted from public 510(k) summary text (heuristic).