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MatrixMIDFACE
Model 04.503.208.01 · Synthes GmbH · DI 10887587018843
DZL — Screw, Fixation, Intraosseous · Class II · 21 CFR 872.4880
JEY — Plate, Bone · Class II · 21 CFR 872.4760
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 (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
1.35
2019-02
0
1.33
2019-03
0
2.28
2019-04
0
2.95
2019-05
0
3.31
2019-06
0
1.56
2019-07
0
1.74
2019-08
0
1.8
2019-09
0
2.1
2019-10
0
2.24
2019-11
0
1.82
2019-12
0
2.16
2020-01
0
2.32
2020-02
0
1.79
2020-03
0
2
2020-04
0
2.1
2020-05
0
2.31
2020-06
0
1.9
2020-07
0
2.11
2020-08
0
2.22
2020-09
0
2
2020-10
0
2.1
2020-11
0
1.68
2020-12
0
1.71
2021-01
0
2.25
2021-02
0
1.39
2021-03
0
2
2021-04
0
3.2
2021-05
0
3.5
2021-06
0
2
2021-07
0
1.27
2021-08
0
3
2021-09
0
1.57
2021-10
0
1.95
2021-11
0
1.92
2021-12
0
3.68
2022-01
0
2.1
2022-02
0
2.45
2022-03
0
3.41
2022-04
0
2.38
2022-05
0
4.31
2022-06
0
2.33
2022-07
0
2.15
2022-08
0
2.68
2022-09
0
1.64
2022-10
0
7.06
2022-11
0
2.5
2022-12
0
4.91
2023-01
0
2.67
2023-02
0
3.14
2023-03
0
4.83
2023-04
0
1.5
2023-05
0
2.73
2023-06
0
4
2023-07
0
3.61
2023-08
0
2.82
2023-09
0
2.63
2023-10
0
1.31
2023-11
0
2.52
2023-12
0
2.3
2024-01
0
3.42
2024-02
0
2.65
2024-03
0
2.06
2024-04
0
2.36
2024-05
0
2.2
2024-06
0
1.71
2024-07
0
1.69
2024-08
0
1.5
2024-09
0
2.28
2024-10
0
2.07
2024-11
0
1.78
2024-12
0
1.73
2025-01
0
2
2025-02
0
1.3
2025-03
0
2
2025-04
0
1.75
2025-05
0
2.12
2025-06
0
2.07
2025-07
0
3.46
2025-08
0
2.5
2025-09
0
1.71
2025-10
0
1.95
2025-11
0
1.56
2025-12
0
4.09
2026-01
0
1.55
2026-02
0
2.14
2026-03
0
1.1
2026-04
0
2.79
2026-05
0
1.96
2026-06
0
3.26
This device (reports/month)Average device in DZL, JEY (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K050608 — cited as predicate by K091812, K102641, K173039, K192655, K192702, K233874
K083388 — cited as predicate by K170272, K173039, K182758, K192655, K233874
Lineage extracted from public 510(k) summary text (heuristic).