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ENNOVATE
Model SY001TS · Aesculap AG · DI 04046964989728
NKB — Thoracolumbosacral Pedicle Screw System · Class II · 21 CFR 888.3070
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 (1)
Initiated
Recall #
Class
Status
Reason
Link basis
2022-07-15
Z-1638-2022
Class II
Open, Classified
Potential for the incorrect screw to be included in the package.
code info di
Adverse-event reports — MAUDE (84)
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.
Injury: 70 · Malfunction: 14
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
2
2.15
2019-02
8
2.14
2019-03
0
1.93
2019-04
2
2.11
2019-05
0
2.3
2019-06
0
2.57
2019-07
0
1.67
2019-08
0
3
2019-09
0
1.75
2019-10
0
1.92
2019-11
0
2.44
2019-12
2
1.59
2020-01
2
2.43
2020-02
2
2.23
2020-03
4
2.38
2020-04
2
1.6
2020-05
0
2.71
2020-06
0
1.75
2020-07
0
2.06
2020-08
0
2.08
2020-09
0
2.52
2020-10
2
2.75
2020-11
0
2.36
2020-12
0
1.97
2021-01
0
2.4
2021-02
0
1.89
2021-03
3
2.61
2021-04
4
2.4
2021-05
0
2
2021-06
9
2.4
2021-07
0
2.27
2021-08
6
2.02
2021-09
2
1.95
2021-10
2
2.57
2021-11
0
2.35
2021-12
2
2.54
2022-01
6
2.18
2022-02
0
2.12
2022-03
0
1.9
2022-04
0
2.06
2022-05
0
1.9
2022-06
0
2.09
2022-07
6
4.92
2022-08
0
1.8
2022-09
0
2.66
2022-10
0
1.61
2022-11
2
1.8
2022-12
8
2.27
2023-01
0
1.97
2023-02
0
1.85
2023-03
0
1.64
2023-04
2
1.92
2023-05
0
1.56
2023-06
0
1.75
2023-07
2
2.05
2023-08
0
2.22
2023-09
0
2.61
2023-10
0
2.69
2023-11
0
2.46
2023-12
0
1.74
2024-01
0
2.44
2024-02
0
2.29
2024-03
2
3.6
2024-04
0
1.7
2024-05
0
3.68
2024-06
0
3.14
2024-07
0
1.96
2024-08
0
2
2024-09
0
3.67
2024-10
0
2.27
2024-11
0
2.18
2024-12
0
2.1
2025-01
2
2.32
2025-02
0
2.66
2025-03
0
2.4
2025-04
0
2.39
2025-05
0
2.64
2025-06
0
2.25
2025-07
0
1.9
2025-08
0
2.02
2025-09
0
1.81
2025-10
0
1.81
2025-11
0
2.03
2025-12
0
2.7
2026-01
0
2.28
2026-02
0
2.42
2026-03
0
2.37
2026-04
0
1.94
2026-05
0
2.28
2026-06
0
3.87
This device (reports/month)Average device in NKB (reports/device/month)