MIDAS REX LEGEND
Model 7BA20DCL · MEDTRONIC POWERED SURGICAL SOLUTIONS · DI 00763000454661
HBB — Motor, Drill, Pneumatic · Class II · 21 CFR 882.4370
UDILibrary device dossier · generated 2026-09-07 · 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 (0)
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.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.71 |
| 2019-02 | 0 | 3.25 |
| 2019-03 | 0 | 3.75 |
| 2019-04 | 0 | 3.25 |
| 2019-05 | 0 | 3.8 |
| 2019-06 | 0 | 3.33 |
| 2019-07 | 0 | 3.2 |
| 2019-08 | 0 | 2.5 |
| 2019-09 | 0 | 5.25 |
| 2019-10 | 0 | 4.1 |
| 2019-11 | 0 | 3.5 |
| 2019-12 | 0 | 3.83 |
| 2020-01 | 0 | 2.38 |
| 2020-02 | 0 | 2.86 |
| 2020-03 | 0 | 3.11 |
| 2020-04 | 0 | 3.4 |
| 2020-05 | 0 | 3 |
| 2020-06 | 0 | 4.6 |
| 2020-07 | 0 | 3.64 |
| 2020-08 | 0 | 2.33 |
| 2020-09 | 0 | 4.5 |
| 2020-10 | 0 | 3 |
| 2020-11 | 0 | 7.33 |
| 2020-12 | 0 | 3.13 |
| 2021-01 | 0 | 2.44 |
| 2021-02 | 0 | 2.56 |
| 2021-03 | 0 | 5 |
| 2021-04 | 0 | 2.88 |
| 2021-05 | 0 | 4.17 |
| 2021-06 | 0 | 2.16 |
| 2021-07 | 0 | 3 |
| 2021-08 | 0 | 1.29 |
| 2021-09 | 0 | 1.8 |
| 2021-10 | 0 | 1.33 |
| 2021-11 | 0 | 2.33 |
| 2021-12 | 0 | 2.25 |
| 2022-01 | 0 | 1.5 |
| 2022-02 | 0 | 1.75 |
| 2022-03 | 0 | 1.33 |
| 2022-04 | 0 | 1.9 |
| 2022-05 | 0 | 1 |
| 2022-06 | 0 | 2.17 |
| 2022-07 | 0 | 2.07 |
| 2022-08 | 0 | 1.33 |
| 2022-09 | 0 | 1.25 |
| 2022-10 | 0 | 1.71 |
| 2022-11 | 0 | 2.4 |
| 2022-12 | 0 | 1 |
| 2023-01 | 0 | 1.5 |
| 2023-02 | 0 | 1 |
| 2023-03 | 0 | 1.22 |
| 2023-04 | 0 | 1.64 |
| 2023-05 | 0 | 1.2 |
| 2023-06 | 0 | 1.25 |
| 2023-07 | 0 | 1.73 |
| 2023-08 | 0 | 1.43 |
| 2023-09 | 0 | 2 |
| 2023-10 | 0 | 1.88 |
| 2023-11 | 0 | 2 |
| 2023-12 | 0 | 1.57 |
| 2024-01 | 0 | 1.31 |
| 2024-02 | 0 | 1.44 |
| 2024-03 | 0 | 1.6 |
| 2024-04 | 0 | 1.56 |
| 2024-05 | 0 | 1.33 |
| 2024-06 | 0 | 1 |
| 2024-07 | 0 | 1.67 |
| 2024-08 | 0 | 1.57 |
| 2024-09 | 0 | 2.09 |
| 2024-10 | 0 | 1.45 |
| 2024-11 | 0 | 1.46 |
| 2024-12 | 0 | 1.5 |
| 2025-01 | 0 | 1.53 |
| 2025-02 | 0 | 1.71 |
| 2025-03 | 0 | 1.55 |
| 2025-04 | 0 | 1.61 |
| 2025-05 | 0 | 1.82 |
| 2025-06 | 0 | 1.44 |
| 2025-07 | 0 | 1.47 |
| 2025-08 | 0 | 3.25 |
| 2025-09 | 0 | 1.33 |
| 2025-10 | 0 | 2 |
| 2025-11 | 0 | 1.43 |
| 2025-12 | 0 | 2.33 |
| 2026-01 | 0 | 2 |
| 2026-02 | 0 | 1 |
| 2026-03 | 0 | 1.25 |
| 2026-04 | 0 | 1.84 |
| 2026-05 | 0 | 2.71 |
| 2026-06 | 0 | 3.74 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K020069 — cited as predicate by K093361, K163182, K163565, K170312, K193630
K170312 — cites (transitively): K012457 (d1), K020069 (d1), K072315 (d1), K081475 (d1), K121264 (d1), K870157 (d1), K081277 (d2) — cited as predicate by K183515, K191597, K213454
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — MEDTRONIC POWERED SURGICAL SOLUTIONS
- NAI 2024-12-05 Medtronic Powered Surgical Solutions · 0 citations