Adverse-event reports (MAUDE)
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.
50 linked reports Injury 48Malfunction 2
2 3 5 6 2019-01: 0 reports for this device; peer average 3.3/device 2019-02: 0 reports for this device; peer average 2.87/device 2019-03: 0 reports for this device; peer average 3.14/device 2019-04: 0 reports for this device; peer average 3.04/device 2019-05: 0 reports for this device; peer average 2.18/device 2019-06: 0 reports for this device; peer average 1.9/device 2019-07: 2 reports for this device; peer average 1.93/device 2019-08: 4 reports for this device; peer average 2.5/device 2019-09: 2 reports for this device; peer average 2.39/device 2019-10: 2 reports for this device; peer average 2.99/device 2019-11: 0 reports for this device; peer average 2.43/device 2019-12: 3 reports for this device; peer average 2.67/device 2020-01: 0 reports for this device; peer average 3.26/device 2020-02: 3 reports for this device; peer average 3.36/device 2020-03: 6 reports for this device; peer average 3.87/device 2020-04: 0 reports for this device; peer average 2.46/device 2020-05: 0 reports for this device; peer average 2.45/device 2020-06: 0 reports for this device; peer average 2.2/device 2020-07: 0 reports for this device; peer average 3.09/device 2020-08: 3 reports for this device; peer average 2.39/device 2020-09: 0 reports for this device; peer average 2.95/device 2020-10: 3 reports for this device; peer average 2.86/device 2020-11: 0 reports for this device; peer average 2.54/device 2020-12: 0 reports for this device; peer average 3.02/device 2021-01: 0 reports for this device; peer average 2.81/device 2021-02: 0 reports for this device; peer average 2.68/device 2021-03: 0 reports for this device; peer average 2.63/device 2021-04: 0 reports for this device; peer average 2.66/device 2021-05: 0 reports for this device; peer average 2.3/device 2021-06: 0 reports for this device; peer average 3.32/device 2021-07: 4 reports for this device; peer average 3.33/device 2021-08: 0 reports for this device; peer average 3.18/device 2021-09: 2 reports for this device; peer average 3.13/device 2021-10: 0 reports for this device; peer average 2.79/device 2021-11: 0 reports for this device; peer average 2.47/device 2021-12: 0 reports for this device; peer average 2.7/device 2022-01: 0 reports for this device; peer average 2.37/device 2022-02: 0 reports for this device; peer average 2.61/device 2022-03: 0 reports for this device; peer average 3.01/device 2022-04: 2 reports for this device; peer average 2.69/device 2022-05: 0 reports for this device; peer average 2.78/device 2022-06: 0 reports for this device; peer average 2.79/device 2022-07: 0 reports for this device; peer average 2.94/device 2022-08: 2 reports for this device; peer average 3.11/device 2022-09: 0 reports for this device; peer average 2.97/device 2022-10: 0 reports for this device; peer average 3.16/device 2022-11: 0 reports for this device; peer average 2.83/device 2022-12: 0 reports for this device; peer average 2.95/device 2023-01: 0 reports for this device; peer average 3.46/device 2023-02: 0 reports for this device; peer average 3/device 2023-03: 0 reports for this device; peer average 3.15/device 2023-04: 0 reports for this device; peer average 3.03/device 2023-05: 0 reports for this device; peer average 3.01/device 2023-06: 0 reports for this device; peer average 3.27/device 2023-07: 0 reports for this device; peer average 3.02/device 2023-08: 0 reports for this device; peer average 2.9/device 2023-09: 0 reports for this device; peer average 2.88/device 2023-10: 0 reports for this device; peer average 2.35/device 2023-11: 0 reports for this device; peer average 2.42/device 2023-12: 0 reports for this device; peer average 2.67/device 2024-01: 0 reports for this device; peer average 2.49/device 2024-02: 2 reports for this device; peer average 2.6/device 2024-03: 0 reports for this device; peer average 2.64/device 2024-04: 0 reports for this device; peer average 2.36/device 2024-05: 0 reports for this device; peer average 3.45/device 2024-06: 0 reports for this device; peer average 2.87/device 2024-07: 0 reports for this device; peer average 2.39/device 2024-08: 3 reports for this device; peer average 2.92/device 2024-09: 0 reports for this device; peer average 3.17/device 2024-10: 0 reports for this device; peer average 2.58/device 2024-11: 3 reports for this device; peer average 2.41/device 2024-12: 0 reports for this device; peer average 2.15/device 2025-01: 0 reports for this device; peer average 2.41/device 2025-02: 0 reports for this device; peer average 1.82/device 2025-03: 0 reports for this device; peer average 2.21/device 2025-04: 0 reports for this device; peer average 2.48/device 2025-05: 0 reports for this device; peer average 2.34/device 2025-06: 0 reports for this device; peer average 2.28/device 2025-07: 0 reports for this device; peer average 2.49/device 2025-08: 0 reports for this device; peer average 2.47/device 2025-09: 2 reports for this device; peer average 2.18/device 2025-10: 0 reports for this device; peer average 2.31/device 2025-11: 0 reports for this device; peer average 2.09/device 2025-12: 0 reports for this device; peer average 2.23/device 2026-01: 0 reports for this device; peer average 2.25/device 2026-02: 0 reports for this device; peer average 2.22/device 2026-03: 0 reports for this device; peer average 2.35/device 2026-04: 2 reports for this device; peer average 2.34/device 2026-05: 0 reports for this device; peer average 2.07/device 2026-06: 0 reports for this device; peer average 2.38/device 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 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 3.3 2019-02 0 2.87 2019-03 0 3.14 2019-04 0 3.04 2019-05 0 2.18 2019-06 0 1.9 2019-07 2 1.93 2019-08 4 2.5 2019-09 2 2.39 2019-10 2 2.99 2019-11 0 2.43 2019-12 3 2.67 2020-01 0 3.26 2020-02 3 3.36 2020-03 6 3.87 2020-04 0 2.46 2020-05 0 2.45 2020-06 0 2.2 2020-07 0 3.09 2020-08 3 2.39 2020-09 0 2.95 2020-10 3 2.86 2020-11 0 2.54 2020-12 0 3.02 2021-01 0 2.81 2021-02 0 2.68 2021-03 0 2.63 2021-04 0 2.66 2021-05 0 2.3 2021-06 0 3.32 2021-07 4 3.33 2021-08 0 3.18 2021-09 2 3.13 2021-10 0 2.79 2021-11 0 2.47 2021-12 0 2.7 2022-01 0 2.37 2022-02 0 2.61 2022-03 0 3.01 2022-04 2 2.69 2022-05 0 2.78 2022-06 0 2.79 2022-07 0 2.94 2022-08 2 3.11 2022-09 0 2.97 2022-10 0 3.16 2022-11 0 2.83 2022-12 0 2.95 2023-01 0 3.46 2023-02 0 3 2023-03 0 3.15 2023-04 0 3.03 2023-05 0 3.01 2023-06 0 3.27 2023-07 0 3.02 2023-08 0 2.9 2023-09 0 2.88 2023-10 0 2.35 2023-11 0 2.42 2023-12 0 2.67 2024-01 0 2.49 2024-02 2 2.6 2024-03 0 2.64 2024-04 0 2.36 2024-05 0 3.45 2024-06 0 2.87 2024-07 0 2.39 2024-08 3 2.92 2024-09 0 3.17 2024-10 0 2.58 2024-11 3 2.41 2024-12 0 2.15 2025-01 0 2.41 2025-02 0 1.82 2025-03 0 2.21 2025-04 0 2.48 2025-05 0 2.34 2025-06 0 2.28 2025-07 0 2.49 2025-08 0 2.47 2025-09 2 2.18 2025-10 0 2.31 2025-11 0 2.09 2025-12 0 2.23 2026-01 0 2.25 2026-02 0 2.22 2026-03 0 2.35 2026-04 2 2.34 2026-05 0 2.07 2026-06 0 2.38
This device (reports/month) Average device in LWJ, MRA (reports/device/month)Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Date Report # Type Narrative Link basis 2026-04-11 3010536692-2026-00072 Injury Available catalog number 2025-09-08 3010536692-2025-00319 Injury Available catalog number 2024-11-04 3010536692-2024-00388 Injury Available catalog number 2024-08-22 3010536692-2024-00432 Injury Available catalog number 2024-02-28 3010536692-2024-00117 Injury Available catalog number 2022-08-11 3010536692-2022-00283 Injury Available catalog number 2022-04-28 3010536692-2022-00150 Injury Available catalog number 2021-09-18 3010536692-2021-00380 Injury Available catalog number 2021-07-13 3010536692-2021-00381 Injury Available catalog number 2021-07-07 3010536692-2021-00352 Injury Available catalog number 2020-10-30 3010536692-2020-00673 Injury Available catalog number 2020-08-04 3010536692-2020-00545 Injury Available catalog number 2020-03-31 3010536692-2020-00308 Injury Available catalog number 2020-03-06 3010536692-2020-00193 Injury Available catalog number 2020-02-18 3010536692-2020-00137 Injury Available catalog number
Showing the most recent 21 of 50 linked reports.
Showing 1–15 of 21 ‹ Prev Next ›
Manufacturer compliance record
Date Type Outcome Facility Citations 2023-02-08 NAI No action indicated MicroPort Orthopedics Inc. 0 2023-02-08 NAI No action indicated MicroPort Orthopedics Inc. 0 2018-06-29 VAI Voluntary action indicated MicroPort Orthopedics Inc. 2 2018-06-29 VAI Voluntary action indicated MicroPort Orthopedics Inc. 2 2015-08-19 VAI Voluntary action indicated MicroPort Orthopedics Inc. 5 2015-08-19 VAI Voluntary action indicated MicroPort Orthopedics Inc. 5 2015-06-17 WL Warning Letter MicroPort Orthopedics Inc. — 2015-06-17 WL Warning Letter MicroPort Orthopedics Inc. —
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