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GRYPHON ORTHOCORD
Model 210030 · Medos International Sàrl · DI 10886705019939
HTY — Pin, Fixation, Smooth · Class II · 21 CFR 888.3040
HWC — Screw, Fixation, Bone · Class II · 21 CFR 888.3040
JDR — Staple, Fixation, Bone · Class II · 21 CFR 888.3030
MAI — Fastener, Fixation, Biodegradable, Soft Tissue · Class II · 21 CFR 888.3030
MBI — Fastener, Fixation, Nondegradable, Soft Tissue · Class II · 21 CFR 888.3040
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 (31)
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: 31
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
1
3.54
2019-02
0
1.87
2019-03
0
2.04
2019-04
0
2.45
2019-05
0
2.22
2019-06
0
2.15
2019-07
0
2.45
2019-08
0
2.4
2019-09
0
2.54
2019-10
0
2.34
2019-11
0
3.11
2019-12
0
3.28
2020-01
0
3.2
2020-02
0
2.57
2020-03
0
2.65
2020-04
0
3.16
2020-05
0
2.36
2020-06
0
2.68
2020-07
0
2.88
2020-08
0
3.06
2020-09
0
2.84
2020-10
0
3.01
2020-11
0
4
2020-12
0
3.65
2021-01
0
2.77
2021-02
0
2.94
2021-03
0
3.06
2021-04
0
3.16
2021-05
0
3.13
2021-06
1
2.88
2021-07
0
2.82
2021-08
0
2.84
2021-09
0
3.14
2021-10
0
3.16
2021-11
0
3.13
2021-12
0
3.24
2022-01
0
3.6
2022-02
0
2.76
2022-03
0
2.94
2022-04
0
2.69
2022-05
0
2.91
2022-06
0
2.81
2022-07
0
2.76
2022-08
0
3.25
2022-09
0
3.21
2022-10
5
3.57
2022-11
0
2.8
2022-12
0
4.31
2023-01
1
3.23
2023-02
0
2.94
2023-03
0
3.37
2023-04
2
3.35
2023-05
4
3.73
2023-06
0
3.66
2023-07
1
2.95
2023-08
1
3.16
2023-09
0
3.27
2023-10
0
3.21
2023-11
1
3.24
2023-12
0
3.89
2024-01
4
4.03
2024-02
1
3.06
2024-03
3
3.52
2024-04
1
3.49
2024-05
1
4.03
2024-06
0
4.49
2024-07
0
3.24
2024-08
0
3.03
2024-09
0
3.49
2024-10
0
3.47
2024-11
0
3.32
2024-12
0
3.68
2025-01
0
3.9
2025-02
0
3.43
2025-03
1
3.36
2025-04
0
3.68
2025-05
1
3.91
2025-06
0
3.73
2025-07
2
3.7
2025-08
0
3.75
2025-09
0
3.46
2025-10
0
3.78
2025-11
0
3.85
2025-12
0
4.64
2026-01
0
4.1
2026-02
0
4.3
2026-03
0
4.3
2026-04
0
4.13
2026-05
0
4.85
2026-06
0
4.54
This device (reports/month)Average device in HTY, HWC, JDR, MAI, MBI (reports/device/month)