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Midas Rex MR8
Model EM800 · MEDTRONIC POWERED SURGICAL SOLUTIONS · DI 00643169912106
ERL — Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece · Class II · 21 CFR 874.4250
HBC — Motor, Drill, Electric · Class II · 21 CFR 882.4360
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 (158)
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: 156 · Injury: 2
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
3.63
2019-02
0
3.47
2019-03
0
6.65
2019-04
0
5.33
2019-05
0
3.84
2019-06
0
4.13
2019-07
0
3.97
2019-08
0
5.07
2019-09
0
4.04
2019-10
0
4.08
2019-11
0
4.92
2019-12
0
4.9
2020-01
0
4.4
2020-02
0
3.85
2020-03
0
4.71
2020-04
0
4.38
2020-05
0
2.91
2020-06
0
5.59
2020-07
0
5.3
2020-08
0
4.34
2020-09
0
4.43
2020-10
0
4.86
2020-11
0
4.61
2020-12
0
5.15
2021-01
0
4.43
2021-02
0
4.85
2021-03
0
5.58
2021-04
0
4.33
2021-05
0
4.46
2021-06
0
5.41
2021-07
0
4.46
2021-08
1
4.65
2021-09
1
3.79
2021-10
1
3.05
2021-11
0
4.11
2021-12
2
3.53
2022-01
0
3.42
2022-02
1
3.14
2022-03
0
3.33
2022-04
2
3.66
2022-05
1
2.9
2022-06
1
4.17
2022-07
1
3.85
2022-08
3
4.25
2022-09
2
3.68
2022-10
3
3.9
2022-11
1
4.43
2022-12
3
4.24
2023-01
3
3.46
2023-02
0
3.87
2023-03
3
4.25
2023-04
1
4.18
2023-05
1
4.89
2023-06
0
3.97
2023-07
0
4.53
2023-08
1
3.58
2023-09
0
3.89
2023-10
1
3.49
2023-11
2
3.68
2023-12
3
3.38
2024-01
3
4.02
2024-02
2
4.52
2024-03
1
4.16
2024-04
0
4.2
2024-05
0
3.15
2024-06
3
3.45
2024-07
4
3.53
2024-08
3
3.48
2024-09
32
5.09
2024-10
4
3.83
2024-11
4
3.54
2024-12
9
3.63
2025-01
2
3.21
2025-02
13
7.11
2025-03
28
6.45
2025-04
4
3.01
2025-05
2
4.04
2025-06
0
3.42
2025-07
3
4.07
2025-08
0
3.49
2025-09
1
3.15
2025-10
0
3.97
2025-11
0
3.17
2025-12
2
3.28
2026-01
0
2.62
2026-02
0
3.27
2026-03
0
3.63
2026-04
0
4.94
2026-05
0
3.86
2026-06
0
3.56
This device (reports/month)Average device in ERL, HBC (reports/device/month)