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OLYMPIC
Model ABBA00000 · Astura Medical · DI 00841379176688
KWP — Appliance, Fixation, Spinal Interlaminal · Class II · 21 CFR 888.3050
NKB — Thoracolumbosacral Pedicle Screw System · Class II · 21 CFR 888.3070
OLO — Orthopedic Stereotaxic Instrument · Class II · 21 CFR 882.4560
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 (5)
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: 5
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
2.35
2019-02
0
2.67
2019-03
0
2.43
2019-04
0
2.37
2019-05
0
2.65
2019-06
0
2.56
2019-07
0
2.16
2019-08
0
2.83
2019-09
0
2.25
2019-10
0
2.63
2019-11
0
3.44
2019-12
0
2.24
2020-01
0
2.8
2020-02
0
3.26
2020-03
0
3.02
2020-04
0
3.8
2020-05
0
2.41
2020-06
0
2.32
2020-07
0
2.53
2020-08
0
2.21
2020-09
0
2.79
2020-10
0
3.93
2020-11
0
3.28
2020-12
0
2.79
2021-01
0
3.16
2021-02
0
2.67
2021-03
0
2.9
2021-04
0
2.79
2021-05
0
2.91
2021-06
0
2.78
2021-07
0
4.68
2021-08
0
2.23
2021-09
0
2.17
2021-10
0
2.36
2021-11
0
2.62
2021-12
0
2.41
2022-01
0
2.28
2022-02
0
2.41
2022-03
0
2.33
2022-04
0
2.18
2022-05
0
2.73
2022-06
0
2.92
2022-07
0
3.83
2022-08
0
2.24
2022-09
0
2.58
2022-10
0
2.25
2022-11
0
2.35
2022-12
0
2.85
2023-01
0
2.36
2023-02
0
2.48
2023-03
0
2.5
2023-04
0
2.42
2023-05
0
2.1
2023-06
0
2.02
2023-07
0
2.22
2023-08
0
2.06
2023-09
2
3.21
2023-10
0
2.84
2023-11
0
5.05
2023-12
0
2.84
2024-01
0
2.65
2024-02
0
3.04
2024-03
0
3.77
2024-04
0
2.48
2024-05
0
3.98
2024-06
0
3.25
2024-07
0
2.67
2024-08
0
2.85
2024-09
0
3.65
2024-10
0
3.9
2024-11
0
3.21
2024-12
0
2.78
2025-01
0
5.1
2025-02
0
3.33
2025-03
0
2.81
2025-04
0
3.1
2025-05
3
3.34
2025-06
0
3.16
2025-07
0
2.91
2025-08
0
3.43
2025-09
0
2.72
2025-10
0
2.99
2025-11
0
2.92
2025-12
0
3.47
2026-01
0
3.3
2026-02
0
3.13
2026-03
0
3.1
2026-04
0
2.82
2026-05
0
3.53
2026-06
0
4.02
This device (reports/month)Average device in KWP, NKB, OLO (reports/device/month)