Read this first: 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 shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
1 linked reportInjury 1
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
4.67
2019-02
0
2.34
2019-03
0
3.13
2019-04
0
3.17
2019-05
0
3.26
2019-06
0
2.82
2019-07
0
3.81
2019-08
0
3.49
2019-09
0
3.35
2019-10
0
3.19
2019-11
0
5.28
2019-12
0
5.45
2020-01
0
5.46
2020-02
0
4.5
2020-03
0
3.98
2020-04
0
5.42
2020-05
0
3.88
2020-06
0
3.71
2020-07
0
3.74
2020-08
0
4.23
2020-09
0
4.05
2020-10
0
4.53
2020-11
0
6.39
2020-12
0
5.41
2021-01
0
4.74
2021-02
0
3.95
2021-03
0
3.83
2021-04
0
3.82
2021-05
0
4.06
2021-06
0
4.11
2021-07
0
4
2021-08
0
4.46
2021-09
0
4.05
2021-10
0
4.44
2021-11
0
4.37
2021-12
0
4.43
2022-01
0
4
2022-02
0
3.37
2022-03
0
3.88
2022-04
0
3.8
2022-05
0
4.06
2022-06
0
3.85
2022-07
0
3.56
2022-08
0
4.39
2022-09
0
3.86
2022-10
0
4.15
2022-11
0
2.87
2022-12
0
3.93
2023-01
0
3.27
2023-02
0
3.2
2023-03
0
3.8
2023-04
0
4.26
2023-05
0
4.67
2023-06
0
4.2
2023-07
0
3.85
2023-08
0
4.49
2023-09
0
4.47
2023-10
0
4.71
2023-11
0
4.63
2023-12
0
5.49
2024-01
0
5.56
2024-02
0
4.93
2024-03
0
4.78
2024-04
0
5.43
2024-05
0
6.48
2024-06
0
7.52
2024-07
0
4.11
2024-08
0
4.21
2024-09
0
5
2024-10
0
4.7
2024-11
0
4.41
2024-12
0
4.25
2025-01
0
5.12
2025-02
0
4.81
2025-03
0
4.57
2025-04
0
4.98
2025-05
1
5.81
2025-06
0
5.47
2025-07
0
5.19
2025-08
0
5.08
2025-09
0
4.29
2025-10
0
4.62
2025-11
0
5.25
2025-12
0
6.07
2026-01
0
5.06
2026-02
0
5.39
2026-03
0
5.98
2026-04
0
5.93
2026-05
0
5.88
2026-06
0
6.16
This device (reports/month)Average device in MBI (reports/device/month)
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
Recall history
Initiated
Recall #
Class
Status
Reason
Quantity
Link basis
2023-05-04
Z-2060-2023
Class II
Open, Classified
Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injury.Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Japan, Netherlands.
N/A
clearance family
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2025-05-07
8043971-0187-02024
Injury
Available
exact di
Regulatory clearances
510(k)K210498Substantially equivalent (SESE) · 2021-03-24clearance family
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.