Print-ready dossier — use your browser's print dialog to save as PDF.
Spine & Trauma 3D Navigation
Model 1.0 · Brainlab SE · DI 04056481140328
HAW — Neurological Stereotaxic Instrument · Class II · 21 CFR 882.4560
OLO — Orthopedic Stereotaxic Instrument · Class II · 21 CFR 882.4560
UDILibrary device dossier · generated 2026-09-15 · 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
2019-02-27
Z-1082-2019
Class I
Terminated
In certain occurrences, the affected navigation software application might unexpectedly display a navigated instrument in an axial, coronal/sagittal (ACS) view representation with fixed planes in the image reconstruction (the not-updated ACS view ), instead of displaying the desirable view representation Inline View , which is commonly used for navigating invasive instruments at the spine. This could lead the surgeon to be unable to determine the position of the navigated instrument. This might occur after a crash restore or after changing between different navigation workflows during the same patient treatment.
code info di
Adverse-event reports — MAUDE (4)
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: 4
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
9.11
2019-02
0
9.71
2019-03
0
9.79
2019-04
0
11.87
2019-05
0
13.04
2019-06
0
13.02
2019-07
0
9.88
2019-08
1
7.49
2019-09
0
7.85
2019-10
0
7.27
2019-11
0
9.91
2019-12
0
10.08
2020-01
0
8.04
2020-02
1
9.15
2020-03
0
9.62
2020-04
0
9.53
2020-05
0
11.43
2020-06
0
8.71
2020-07
0
9.7
2020-08
0
8.58
2020-09
0
8.91
2020-10
0
9.9
2020-11
0
10.94
2020-12
0
9.27
2021-01
0
9.05
2021-02
0
9.77
2021-03
0
9.35
2021-04
0
8.9
2021-05
0
9.8
2021-06
0
11.37
2021-07
0
8.74
2021-08
0
10.53
2021-09
1
13
2021-10
0
8.34
2021-11
0
11.01
2021-12
0
7.44
2022-01
0
6.82
2022-02
0
7.95
2022-03
0
9.35
2022-04
0
6.39
2022-05
0
8.87
2022-06
0
9.36
2022-07
0
8.79
2022-08
0
8.72
2022-09
0
8.74
2022-10
0
11.56
2022-11
0
10.32
2022-12
0
10.44
2023-01
0
9.14
2023-02
0
8.45
2023-03
0
10.04
2023-04
0
10.25
2023-05
1
10.82
2023-06
0
12.34
2023-07
0
14.14
2023-08
0
13.16
2023-09
0
11.4
2023-10
0
10.8
2023-11
0
14.61
2023-12
0
12.27
2024-01
0
16.51
2024-02
0
12.43
2024-03
0
14.98
2024-04
0
13.44
2024-05
0
12.95
2024-06
0
12.52
2024-07
0
13.91
2024-08
0
18.98
2024-09
0
14.7
2024-10
0
18.36
2024-11
0
10.72
2024-12
0
10.63
2025-01
0
12.32
2025-02
0
13.73
2025-03
0
12.56
2025-04
0
13.77
2025-05
0
13.22
2025-06
0
16.69
2025-07
0
12.44
2025-08
0
10.63
2025-09
0
11.02
2025-10
0
10.7
2025-11
0
9.45
2025-12
0
8.85
2026-01
0
10.24
2026-02
0
8.24
2026-03
0
8.88
2026-04
0
7.34
2026-05
0
7.59
2026-06
0
5.85
This device (reports/month)Average device in HAW, OLO (reports/device/month)