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.
9 linked reports Injury 9
2 3 5 6 2019-01: 0 reports for this device; peer average 2.23/device 2019-02: 0 reports for this device; peer average 2.95/device 2019-03: 0 reports for this device; peer average 1.95/device 2019-04: 0 reports for this device; peer average 2.54/device 2019-05: 0 reports for this device; peer average 2.58/device 2019-06: 0 reports for this device; peer average 2.13/device 2019-07: 0 reports for this device; peer average 2.88/device 2019-08: 0 reports for this device; peer average 2.31/device 2019-09: 0 reports for this device; peer average 2.59/device 2019-10: 0 reports for this device; peer average 3.55/device 2019-11: 0 reports for this device; peer average 2.61/device 2019-12: 0 reports for this device; peer average 3.08/device 2020-01: 0 reports for this device; peer average 2.65/device 2020-02: 0 reports for this device; peer average 2.14/device 2020-03: 0 reports for this device; peer average 2.57/device 2020-04: 0 reports for this device; peer average 2.06/device 2020-05: 0 reports for this device; peer average 2.2/device 2020-06: 0 reports for this device; peer average 2.79/device 2020-07: 0 reports for this device; peer average 3.4/device 2020-08: 0 reports for this device; peer average 3.22/device 2020-09: 0 reports for this device; peer average 3.04/device 2020-10: 0 reports for this device; peer average 3.82/device 2020-11: 0 reports for this device; peer average 4.24/device 2020-12: 0 reports for this device; peer average 3.5/device 2021-01: 0 reports for this device; peer average 4.53/device 2021-02: 0 reports for this device; peer average 3.6/device 2021-03: 0 reports for this device; peer average 3.73/device 2021-04: 0 reports for this device; peer average 3.42/device 2021-05: 0 reports for this device; peer average 3.39/device 2021-06: 0 reports for this device; peer average 3.09/device 2021-07: 0 reports for this device; peer average 3.34/device 2021-08: 0 reports for this device; peer average 2.55/device 2021-09: 0 reports for this device; peer average 3.23/device 2021-10: 0 reports for this device; peer average 2.68/device 2021-11: 0 reports for this device; peer average 3.38/device 2021-12: 0 reports for this device; peer average 3.64/device 2022-01: 0 reports for this device; peer average 3.69/device 2022-02: 0 reports for this device; peer average 3.36/device 2022-03: 0 reports for this device; peer average 3.02/device 2022-04: 0 reports for this device; peer average 3.35/device 2022-05: 0 reports for this device; peer average 2.79/device 2022-06: 0 reports for this device; peer average 2.88/device 2022-07: 0 reports for this device; peer average 3.37/device 2022-08: 0 reports for this device; peer average 3.33/device 2022-09: 0 reports for this device; peer average 4.38/device 2022-10: 0 reports for this device; peer average 2.97/device 2022-11: 0 reports for this device; peer average 3.63/device 2022-12: 0 reports for this device; peer average 3.15/device 2023-01: 0 reports for this device; peer average 3.5/device 2023-02: 0 reports for this device; peer average 3.32/device 2023-03: 0 reports for this device; peer average 3.94/device 2023-04: 0 reports for this device; peer average 3.01/device 2023-05: 0 reports for this device; peer average 4.21/device 2023-06: 0 reports for this device; peer average 3.57/device 2023-07: 6 reports for this device; peer average 3.65/device 2023-08: 0 reports for this device; peer average 2.96/device 2023-09: 0 reports for this device; peer average 2.53/device 2023-10: 0 reports for this device; peer average 2.7/device 2023-11: 0 reports for this device; peer average 2.46/device 2023-12: 0 reports for this device; peer average 2.32/device 2024-01: 0 reports for this device; peer average 2.51/device 2024-02: 0 reports for this device; peer average 2.89/device 2024-03: 0 reports for this device; peer average 2.61/device 2024-04: 0 reports for this device; peer average 2.38/device 2024-05: 0 reports for this device; peer average 3.31/device 2024-06: 0 reports for this device; peer average 3/device 2024-07: 0 reports for this device; peer average 3.19/device 2024-08: 0 reports for this device; peer average 2.25/device 2024-09: 0 reports for this device; peer average 3.85/device 2024-10: 0 reports for this device; peer average 2.67/device 2024-11: 0 reports for this device; peer average 2.56/device 2024-12: 0 reports for this device; peer average 1.94/device 2025-01: 0 reports for this device; peer average 5.71/device 2025-02: 0 reports for this device; peer average 4.27/device 2025-03: 0 reports for this device; peer average 2.71/device 2025-04: 0 reports for this device; peer average 2.89/device 2025-05: 0 reports for this device; peer average 3.18/device 2025-06: 0 reports for this device; peer average 2.74/device 2025-07: 0 reports for this device; peer average 2.97/device 2025-08: 0 reports for this device; peer average 3.06/device 2025-09: 0 reports for this device; peer average 2.47/device 2025-10: 0 reports for this device; peer average 2.19/device 2025-11: 0 reports for this device; peer average 2.86/device 2025-12: 0 reports for this device; peer average 3.46/device 2026-01: 0 reports for this device; peer average 3.06/device 2026-02: 0 reports for this device; peer average 2.46/device 2026-03: 0 reports for this device; peer average 2.72/device 2026-04: 0 reports for this device; peer average 2.96/device 2026-05: 0 reports for this device; peer average 2.98/device 2026-06: 3 reports for this device; peer average 3.27/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 2.23 2019-02 0 2.95 2019-03 0 1.95 2019-04 0 2.54 2019-05 0 2.58 2019-06 0 2.13 2019-07 0 2.88 2019-08 0 2.31 2019-09 0 2.59 2019-10 0 3.55 2019-11 0 2.61 2019-12 0 3.08 2020-01 0 2.65 2020-02 0 2.14 2020-03 0 2.57 2020-04 0 2.06 2020-05 0 2.2 2020-06 0 2.79 2020-07 0 3.4 2020-08 0 3.22 2020-09 0 3.04 2020-10 0 3.82 2020-11 0 4.24 2020-12 0 3.5 2021-01 0 4.53 2021-02 0 3.6 2021-03 0 3.73 2021-04 0 3.42 2021-05 0 3.39 2021-06 0 3.09 2021-07 0 3.34 2021-08 0 2.55 2021-09 0 3.23 2021-10 0 2.68 2021-11 0 3.38 2021-12 0 3.64 2022-01 0 3.69 2022-02 0 3.36 2022-03 0 3.02 2022-04 0 3.35 2022-05 0 2.79 2022-06 0 2.88 2022-07 0 3.37 2022-08 0 3.33 2022-09 0 4.38 2022-10 0 2.97 2022-11 0 3.63 2022-12 0 3.15 2023-01 0 3.5 2023-02 0 3.32 2023-03 0 3.94 2023-04 0 3.01 2023-05 0 4.21 2023-06 0 3.57 2023-07 6 3.65 2023-08 0 2.96 2023-09 0 2.53 2023-10 0 2.7 2023-11 0 2.46 2023-12 0 2.32 2024-01 0 2.51 2024-02 0 2.89 2024-03 0 2.61 2024-04 0 2.38 2024-05 0 3.31 2024-06 0 3 2024-07 0 3.19 2024-08 0 2.25 2024-09 0 3.85 2024-10 0 2.67 2024-11 0 2.56 2024-12 0 1.94 2025-01 0 5.71 2025-02 0 4.27 2025-03 0 2.71 2025-04 0 2.89 2025-05 0 3.18 2025-06 0 2.74 2025-07 0 2.97 2025-08 0 3.06 2025-09 0 2.47 2025-10 0 2.19 2025-11 0 2.86 2025-12 0 3.46 2026-01 0 3.06 2026-02 0 2.46 2026-03 0 2.72 2026-04 0 2.96 2026-05 0 2.98 2026-06 3 3.27
Failure-mode summaryAI-generated
9 linked report narratives available — no AI summary generated yet.
Date Report # Type Narrative Link basis 2026-06-30 3005739886-2026-00031 Injury Available catalog number 2023-07-17 3005739886-2023-00031 Injury Available catalog number 2023-07-17 3005739886-2023-00030 Injury Available catalog number
Showing the most recent 3 of 9 linked reports.
Manufacturer compliance record
Date Type Outcome Facility Citations 2017-08-11 NAI No action indicated Precision Spine Inc 0
Final Tightening Driver, Short INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED """1.0MM"" SYSTEM" BIOMET MICROFIXATION, INC """1.0MM"" SYSTEM" BIOMET MICROFIXATION, INC """1.0MM"" SYSTEM" BIOMET MICROFIXATION, INC """2.0 MM"" SYSTEM" BIOMET MICROFIXATION, INC "3/4"" HEX DRIVER" Biomet Orthopedics, LLC .050 Driver, Latch Osteocentric Technologies, Inc. .050 Driver, Long Osteocentric Technologies, Inc. .050 Driver, Short Osteocentric Technologies, Inc. 1.3 SQUARE SCREWDRIVER Biomet Orthopedics, LLC 1.3 SQUARE SCREWDRIVER Biomet Orthopedics, LLC 1.5MM SYSTEM BIOMET MICROFIXATION, INC Compare Select up to two to place side-by-side with this device.