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.
5 linked reportsInjury 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
1.83
2019-02
0
2
2019-03
0
1
2019-04
0
2
2019-05
0
2
2019-06
0
1.33
2019-07
0
1.25
2019-08
0
17
2019-09
0
1
2019-10
0
1
2019-11
0
2.67
2019-12
0
3
2020-01
0
5
2020-02
0
2
2020-03
0
1.8
2020-05
0
2.5
2020-06
0
2.33
2020-07
0
1.33
2020-08
0
1.5
2020-10
1
1.33
2020-11
0
2.83
2020-12
0
2.5
2021-01
0
1.5
2021-02
0
3.33
2021-03
0
6
2021-04
0
2.11
2021-05
0
12.29
2021-06
0
2.83
2021-07
0
2
2021-08
0
2
2021-09
0
1.25
2021-10
0
2
2021-11
0
3
2021-12
0
1.5
2022-01
0
2
2022-02
0
2.67
2022-03
0
1.75
2022-04
0
3
2022-05
0
1.33
2022-06
0
3
2022-07
0
2.5
2022-08
0
1.5
2022-09
0
1.67
2022-10
0
1.75
2022-11
0
3
2022-12
0
2
2023-01
0
1.33
2023-02
0
1
2023-03
0
1.2
2023-04
0
1.33
2023-05
0
1.5
2023-06
0
1
2023-07
0
1.2
2023-09
0
1
2023-10
0
1
2023-11
0
3
2024-01
0
1
2024-02
0
1
2024-03
0
1.33
2024-04
0
2
2024-05
0
1.4
2024-06
0
1.5
2024-07
0
1
2024-08
0
1.6
2024-09
0
1
2024-10
0
1
2024-11
0
1.5
2024-12
0
2
2025-01
0
2
2025-02
4
2.83
2025-06
0
1.33
2025-08
0
1
2025-09
0
1
2025-10
0
2
2025-11
0
1.5
2025-12
0
1.25
2026-01
0
1
2026-02
0
2
2026-03
0
1.4
2026-04
0
1
2026-05
0
1.5
2026-06
0
1
This device (reports/month)Average device in JDW (reports/device/month)
Failure-mode summaryAI-generated
5 linked report narratives available — no AI summary generated yet.
Recall history
Initiated
Recall #
Class
Status
Reason
Quantity
Link basis
2026-06-10
Z-2729-2026
Class II
Open, Classified
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111Distribution: US: AZ CA CO CT FL GA ID IL IN LA MD MI MO MS MT NC NY OH OR SC SD TX UT VA WA WI OUS: None
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.