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.
64 linked reports Injury 37Malfunction 27
5 9 14 18 2019-01: 0 reports for this device; peer average 2.04/device 2019-02: 0 reports for this device; peer average 1.58/device 2019-03: 0 reports for this device; peer average 1.74/device 2019-04: 0 reports for this device; peer average 2.29/device 2019-05: 0 reports for this device; peer average 1.72/device 2019-06: 0 reports for this device; peer average 1.74/device 2019-07: 0 reports for this device; peer average 1.9/device 2019-08: 0 reports for this device; peer average 1.85/device 2019-09: 0 reports for this device; peer average 1.72/device 2019-10: 0 reports for this device; peer average 1.62/device 2019-11: 0 reports for this device; peer average 1.89/device 2019-12: 0 reports for this device; peer average 2.26/device 2020-01: 0 reports for this device; peer average 2.4/device 2020-02: 0 reports for this device; peer average 1.44/device 2020-03: 0 reports for this device; peer average 1.78/device 2020-04: 0 reports for this device; peer average 1.9/device 2020-05: 0 reports for this device; peer average 1.76/device 2020-06: 0 reports for this device; peer average 2.01/device 2020-07: 0 reports for this device; peer average 2.34/device 2020-08: 0 reports for this device; peer average 2.42/device 2020-09: 0 reports for this device; peer average 2.58/device 2020-10: 0 reports for this device; peer average 2.09/device 2020-11: 0 reports for this device; peer average 2.65/device 2020-12: 0 reports for this device; peer average 2.39/device 2021-01: 0 reports for this device; peer average 1.82/device 2021-02: 0 reports for this device; peer average 2.14/device 2021-03: 0 reports for this device; peer average 2.38/device 2021-04: 0 reports for this device; peer average 2.76/device 2021-05: 0 reports for this device; peer average 2.5/device 2021-06: 0 reports for this device; peer average 2.14/device 2021-07: 0 reports for this device; peer average 2.29/device 2021-08: 0 reports for this device; peer average 1.99/device 2021-09: 0 reports for this device; peer average 2.21/device 2021-10: 0 reports for this device; peer average 2.05/device 2021-11: 0 reports for this device; peer average 2.19/device 2021-12: 0 reports for this device; peer average 2.29/device 2022-01: 0 reports for this device; peer average 2.92/device 2022-02: 0 reports for this device; peer average 2.13/device 2022-03: 0 reports for this device; peer average 1.89/device 2022-04: 0 reports for this device; peer average 1.98/device 2022-05: 0 reports for this device; peer average 2.2/device 2022-06: 0 reports for this device; peer average 2.27/device 2022-07: 6 reports for this device; peer average 2.21/device 2022-08: 4 reports for this device; peer average 2.3/device 2022-09: 4 reports for this device; peer average 2.7/device 2022-10: 4 reports for this device; peer average 3/device 2022-11: 18 reports for this device; peer average 2.97/device 2022-12: 0 reports for this device; peer average 4.54/device 2023-01: 4 reports for this device; peer average 2.64/device 2023-02: 0 reports for this device; peer average 2.75/device 2023-03: 0 reports for this device; peer average 3.05/device 2023-04: 6 reports for this device; peer average 2.91/device 2023-05: 0 reports for this device; peer average 3.6/device 2023-06: 0 reports for this device; peer average 2.95/device 2023-07: 1 reports for this device; peer average 2.26/device 2023-08: 0 reports for this device; peer average 2.19/device 2023-09: 1 reports for this device; peer average 2.04/device 2023-10: 0 reports for this device; peer average 2.25/device 2023-11: 0 reports for this device; peer average 1.92/device 2023-12: 1 reports for this device; peer average 2.43/device 2024-01: 0 reports for this device; peer average 2.52/device 2024-02: 0 reports for this device; peer average 1.78/device 2024-03: 0 reports for this device; peer average 2.15/device 2024-04: 1 reports for this device; peer average 2.11/device 2024-05: 2 reports for this device; peer average 2.17/device 2024-06: 1 reports for this device; peer average 2.29/device 2024-07: 0 reports for this device; peer average 2.38/device 2024-08: 0 reports for this device; peer average 2.18/device 2024-09: 0 reports for this device; peer average 1.95/device 2024-10: 0 reports for this device; peer average 2.23/device 2024-11: 1 reports for this device; peer average 1.91/device 2024-12: 0 reports for this device; peer average 2.81/device 2025-01: 0 reports for this device; peer average 2/device 2025-02: 0 reports for this device; peer average 2.06/device 2025-03: 0 reports for this device; peer average 2.32/device 2025-04: 0 reports for this device; peer average 2.29/device 2025-05: 0 reports for this device; peer average 2.35/device 2025-06: 4 reports for this device; peer average 1.89/device 2025-07: 3 reports for this device; peer average 2.12/device 2025-08: 0 reports for this device; peer average 2.27/device 2025-09: 0 reports for this device; peer average 1.96/device 2025-10: 0 reports for this device; peer average 2.29/device 2025-11: 0 reports for this device; peer average 1.99/device 2025-12: 0 reports for this device; peer average 2.63/device 2026-01: 0 reports for this device; peer average 1.93/device 2026-02: 1 reports for this device; peer average 2.21/device 2026-03: 2 reports for this device; peer average 2.79/device 2026-04: 0 reports for this device; peer average 2.18/device 2026-05: 0 reports for this device; peer average 2.41/device 2026-06: 0 reports for this device; peer average 2.17/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 2.04 2019-02 0 1.58 2019-03 0 1.74 2019-04 0 2.29 2019-05 0 1.72 2019-06 0 1.74 2019-07 0 1.9 2019-08 0 1.85 2019-09 0 1.72 2019-10 0 1.62 2019-11 0 1.89 2019-12 0 2.26 2020-01 0 2.4 2020-02 0 1.44 2020-03 0 1.78 2020-04 0 1.9 2020-05 0 1.76 2020-06 0 2.01 2020-07 0 2.34 2020-08 0 2.42 2020-09 0 2.58 2020-10 0 2.09 2020-11 0 2.65 2020-12 0 2.39 2021-01 0 1.82 2021-02 0 2.14 2021-03 0 2.38 2021-04 0 2.76 2021-05 0 2.5 2021-06 0 2.14 2021-07 0 2.29 2021-08 0 1.99 2021-09 0 2.21 2021-10 0 2.05 2021-11 0 2.19 2021-12 0 2.29 2022-01 0 2.92 2022-02 0 2.13 2022-03 0 1.89 2022-04 0 1.98 2022-05 0 2.2 2022-06 0 2.27 2022-07 6 2.21 2022-08 4 2.3 2022-09 4 2.7 2022-10 4 3 2022-11 18 2.97 2022-12 0 4.54 2023-01 4 2.64 2023-02 0 2.75 2023-03 0 3.05 2023-04 6 2.91 2023-05 0 3.6 2023-06 0 2.95 2023-07 1 2.26 2023-08 0 2.19 2023-09 1 2.04 2023-10 0 2.25 2023-11 0 1.92 2023-12 1 2.43 2024-01 0 2.52 2024-02 0 1.78 2024-03 0 2.15 2024-04 1 2.11 2024-05 2 2.17 2024-06 1 2.29 2024-07 0 2.38 2024-08 0 2.18 2024-09 0 1.95 2024-10 0 2.23 2024-11 1 1.91 2024-12 0 2.81 2025-01 0 2 2025-02 0 2.06 2025-03 0 2.32 2025-04 0 2.29 2025-05 0 2.35 2025-06 4 1.89 2025-07 3 2.12 2025-08 0 2.27 2025-09 0 1.96 2025-10 0 2.29 2025-11 0 1.99 2025-12 0 2.63 2026-01 0 1.93 2026-02 1 2.21 2026-03 2 2.79 2026-04 0 2.18 2026-05 0 2.41 2026-06 0 2.17
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Date Report # Type Narrative Link basis 2026-03-24 8030965-2026-02768 Malfunction Available exact di 2026-03-24 8030965-2026-02767 Malfunction Available exact di 2026-02-19 8030965-2026-01661 Injury Available exact di 2025-07-28 8030965-2025-07568 Injury Available exact di 2025-07-28 8030965-2025-07561 Injury Available exact di 2025-07-28 8030965-2025-07559 Injury Available exact di 2025-06-27 8030965-2025-06534 Malfunction Available exact di 2025-06-27 8030965-2025-06539 Malfunction Available exact di 2025-06-27 8030965-2025-06533 Malfunction Available exact di 2025-06-27 8030965-2025-06535 Malfunction Available exact di 2024-11-14 8030965-2024-13919 Malfunction Available exact di 2024-06-17 8030965-2024-07558 Malfunction Available exact di 2024-05-15 8030965-2024-06270 Malfunction Available exact di 2024-05-07 8030965-2024-05836 Malfunction Available exact di 2024-04-18 8030965-2024-05254 Malfunction Available exact di
Showing the most recent 41 of 64 linked reports.
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Manufacturer compliance record
Date Type Outcome Facility Citations 2017-08-08 NAI No action indicated Synthes GmbH 0 2017-01-18 NAI No action indicated Synthes (USA), LLC 0 2015-05-08 VAI Voluntary action indicated Synthes (USA), LLC 2 2013-11-13 VAI Voluntary action indicated Synthes, Inc. 1 2013-05-16 NAI No action indicated Synthes, Inc. 0 2012-10-19 VAI Voluntary action indicated Synthes, Inc. 1 2012-02-16 WL Warning Letter Synthes, Inc. — 2012-02-01 NAI No action indicated Synthes (USA), LLC 0 2011-09-15 OAI Official action indicated Synthes, Inc. 10
3.3mm Screw Fastener Self Tapping 14mm Osteocentric Technologies, Inc. 3.3mm Screw Fastener Self Tapping 16mm Osteocentric Technologies, Inc. 3.3mm Screw Fastener Self Tapping 18mm Osteocentric Technologies, Inc. 3.3mm Screw Fastener Self Tapping 20mm Osteocentric Technologies, Inc. 4.0 x 22mm LOCKING BONE SCREW FASTENER ST Osteocentric Technologies, Inc. Biosteon® IntraLine® BIOCOMPOSITES LTD CORTICAL BONE SCREW 3.5mm x 16mm ADVANCED ORTHOPAEDIC SOLUTIONS, INC. CORTICAL BONE SCREW 3.5mm x 20mm ADVANCED ORTHOPAEDIC SOLUTIONS, INC. CORTICAL BONE SCREW 3.5mm x 24mm ADVANCED ORTHOPAEDIC SOLUTIONS, INC. CORTICAL BONE SCREW 3.5mm x 26mm ADVANCED ORTHOPAEDIC SOLUTIONS, INC. Container FOURNITURES HOSPITALIERES INDUSTRIE Locking Fibula Plate, 5 Holes FLOWER ORTHOPEDICS CORPORATION Compare Select up to two to place side-by-side with this device.