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"""1.5MM"" SYSTEM BONE SCREW"
Model 01-7285 · BIOMET MICROFIXATION, INC · DI 00841036013639
GWO — Plate, Cranioplasty, Preformed, Alterable · Class II · 21 CFR 882.5320
GXR — Cover, Burr Hole · Class II · 21 CFR 882.5250
HBW — Fastener, Plate, Cranioplasty · Class II · 21 CFR 882.5360
HWC — Screw, Fixation, Bone · Class II · 21 CFR 888.3040
JEY — Plate, Bone · Class II · 21 CFR 872.4760
UDILibrary device dossier · generated 2026-09-11 · 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
2.02
2019-02
0
1.56
2019-03
0
1.95
2019-04
0
2.29
2019-05
0
1.93
2019-06
0
1.71
2019-07
0
1.96
2019-08
0
2.03
2019-09
0
1.77
2019-10
0
1.79
2019-11
0
1.93
2019-12
0
2.71
2020-01
0
2.53
2020-02
0
2.02
2020-03
0
2.03
2020-04
0
1.91
2020-05
0
1.95
2020-06
0
2.16
2020-07
0
2.63
2020-08
0
2.36
2020-09
0
2.48
2020-10
0
2.2
2020-11
0
2.62
2020-12
0
2.45
2021-01
0
1.86
2021-02
0
2.13
2021-03
0
2.55
2021-04
0
2.9
2021-05
0
2.48
2021-06
0
2.17
2021-07
0
2.09
2021-08
0
2.24
2021-09
0
2.24
2021-10
0
2.13
2021-11
0
2.2
2021-12
0
2.46
2022-01
0
2.83
2022-02
0
2.51
2022-03
0
2.32
2022-04
0
1.91
2022-05
0
2.22
2022-06
0
2.44
2022-07
0
2.16
2022-08
0
2.39
2022-09
0
2.74
2022-10
0
3.24
2022-11
0
2.93
2022-12
0
4.89
2023-01
0
2.68
2023-02
0
2.88
2023-03
0
3.16
2023-04
0
2.99
2023-05
0
3.19
2023-06
0
3.74
2023-07
0
2.37
2023-08
0
2.22
2023-09
0
2.08
2023-10
0
2.13
2023-11
0
1.99
2023-12
0
2.31
2024-01
0
2.84
2024-02
0
1.93
2024-03
0
2.34
2024-04
0
2.26
2024-05
0
2.28
2024-06
0
2.19
2024-07
0
2.32
2024-08
0
2.02
2024-09
0
2.19
2024-10
0
2.46
2024-11
0
2.12
2024-12
0
2.6
2025-01
0
2.13
2025-02
0
2.1
2025-03
0
2.05
2025-04
0
2.43
2025-05
0
2.49
2025-06
0
2.02
2025-07
0
2.37
2025-08
0
2.38
2025-09
0
2
2025-10
0
2.29
2025-11
0
1.9
2025-12
0
3.01
2026-01
0
1.95
2026-02
0
2.35
2026-03
0
2.46
2026-04
0
2.57
2026-05
0
2.53
2026-06
0
2.53
This device (reports/month)Average device in GWO, GXR, HBW, HWC, JEY (reports/device/month)