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.
8 linked reports Malfunction 8
1 3 4 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: 0 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: 2 reports for this device; peer average 4.27/device 2025-03: 0 reports for this device; peer average 2.71/device 2025-04: 2 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: 2 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: 2 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: 0 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 0 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 2 4.27 2025-03 0 2.71 2025-04 2 2.89 2025-05 0 3.18 2025-06 0 2.74 2025-07 0 2.97 2025-08 2 3.06 2025-09 0 2.47 2025-10 0 2.19 2025-11 0 2.86 2025-12 2 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 0 3.27
Failure-mode summaryAI-generated
8 linked report narratives available — no AI summary generated yet.
Date Report # Type Narrative Link basis 2025-12-16 2027467-2025-00280 Malfunction Available exact di 2025-08-12 2027467-2025-00194 Malfunction Available exact di 2025-04-02 2027467-2025-00042 Malfunction Available exact di 2025-02-19 2027467-2025-00015 Malfunction Available exact di
Showing the most recent 4 of 8 linked reports.
Manufacturer compliance record
Date Type Outcome Facility Citations 2017-04-19 VAI Voluntary action indicated Alphatec Spine, Inc. 1 2016-03-16 VAI Voluntary action indicated Alphatec Spine, Inc. 1 2015-07-16 WL Warning Letter Alphatec Spine, Inc. — 2015-03-13 OAI Official action indicated Alphatec Spine, Inc. 0 2013-06-14 NAI No action indicated Alphatec Spine, Inc. 0 2012-04-27 VAI Voluntary action indicated Alphatec Spine, Inc. 0 2011-01-11 WL Warning Letter Alphatec Spine, Inc. — 2010-12-13 VAI Voluntary action indicated Alphatec Spine, Inc. 7 2010-06-21 WL Warning Letter Alphatec Spine, Inc. — 2010-02-11 OAI Official action indicated Alphatec Spine, Inc. 11
Final Tightening Driver, Short INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED MD Vue Lateral Access PRECISION SPINE, INC. MD Vue Lateral Access PRECISION SPINE, INC. """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 Compare Select up to two to place side-by-side with this device.