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.
78 linked reports Malfunction 72Injury 6
3 5 8 10 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: 2 reports for this device; peer average 2.14/device 2020-03: 2 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: 2 reports for this device; peer average 3.23/device 2021-10: 0 reports for this device; peer average 2.68/device 2021-11: 2 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: 2 reports for this device; peer average 3.94/device 2023-04: 2 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: 4 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: 4 reports for this device; peer average 2.51/device 2024-02: 0 reports for this device; peer average 2.89/device 2024-03: 2 reports for this device; peer average 2.61/device 2024-04: 0 reports for this device; peer average 2.38/device 2024-05: 2 reports for this device; peer average 3.31/device 2024-06: 2 reports for this device; peer average 3/device 2024-07: 4 reports for this device; peer average 3.19/device 2024-08: 0 reports for this device; peer average 2.25/device 2024-09: 2 reports for this device; peer average 3.85/device 2024-10: 4 reports for this device; peer average 2.67/device 2024-11: 2 reports for this device; peer average 2.56/device 2024-12: 1 reports for this device; peer average 1.94/device 2025-01: 2 reports for this device; peer average 5.71/device 2025-02: 0 reports for this device; peer average 4.27/device 2025-03: 8 reports for this device; peer average 2.71/device 2025-04: 4 reports for this device; peer average 2.89/device 2025-05: 0 reports for this device; peer average 3.18/device 2025-06: 4 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: 1 reports for this device; peer average 2.47/device 2025-10: 2 reports for this device; peer average 2.19/device 2025-11: 2 reports for this device; peer average 2.86/device 2025-12: 10 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: 2 reports for this device; peer average 2.72/device 2026-04: 2 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 2 2.14 2020-03 2 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 2 3.23 2021-10 0 2.68 2021-11 2 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 2 3.94 2023-04 2 3.01 2023-05 0 4.21 2023-06 0 3.57 2023-07 0 3.65 2023-08 0 2.96 2023-09 4 2.53 2023-10 0 2.7 2023-11 0 2.46 2023-12 0 2.32 2024-01 4 2.51 2024-02 0 2.89 2024-03 2 2.61 2024-04 0 2.38 2024-05 2 3.31 2024-06 2 3 2024-07 4 3.19 2024-08 0 2.25 2024-09 2 3.85 2024-10 4 2.67 2024-11 2 2.56 2024-12 1 1.94 2025-01 2 5.71 2025-02 0 4.27 2025-03 8 2.71 2025-04 4 2.89 2025-05 0 3.18 2025-06 4 2.74 2025-07 0 2.97 2025-08 2 3.06 2025-09 1 2.47 2025-10 2 2.19 2025-11 2 2.86 2025-12 10 3.46 2026-01 0 3.06 2026-02 0 2.46 2026-03 2 2.72 2026-04 2 2.96 2026-05 0 2.98 2026-06 0 3.27
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Date Report # Type Narrative Link basis 2026-04-27 2027467-2026-00075 Malfunction Available exact di 2026-03-05 2027467-2026-00034 Malfunction Available exact di 2025-12-30 2027467-2025-00285 Malfunction Available exact di 2025-12-15 2027467-2025-00272 Malfunction Available exact di 2025-12-01 2027467-2025-00252 Malfunction Available exact di 2025-12-01 2027467-2025-00251 Malfunction Available exact di 2025-12-01 2027467-2025-00250 Malfunction Available exact di 2025-11-04 2027467-2025-00242 Malfunction Available exact di 2025-10-15 2027467-2025-00229 Malfunction Available exact di 2025-09-23 2027467-2025-00220 Malfunction Available model number 2025-08-19 2027467-2025-00207 Malfunction Available exact di 2025-06-18 2027467-2025-00145 Malfunction Available exact di 2025-06-11 2027467-2025-00138 Malfunction Available exact di 2025-04-16 2027467-2025-00084 Malfunction Available exact di 2025-04-11 2027467-2025-00054 Malfunction Available model number
Showing the most recent 42 of 78 linked reports.
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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.