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.
31 linked reports Malfunction 16Injury 15
2 4 6 8 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: 2 reports for this device; peer average 2.21/device 2022-08: 2 reports for this device; peer average 2.3/device 2022-09: 2 reports for this device; peer average 2.7/device 2022-10: 2 reports for this device; peer average 3/device 2022-11: 4 reports for this device; peer average 2.97/device 2022-12: 0 reports for this device; peer average 4.54/device 2023-01: 0 reports for this device; peer average 2.64/device 2023-02: 2 reports for this device; peer average 2.75/device 2023-03: 0 reports for this device; peer average 3.05/device 2023-04: 2 reports for this device; peer average 2.91/device 2023-05: 8 reports for this device; peer average 3.6/device 2023-06: 0 reports for this device; peer average 2.95/device 2023-07: 0 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: 1 reports for this device; peer average 2.25/device 2023-11: 2 reports for this device; peer average 1.92/device 2023-12: 0 reports for this device; peer average 2.43/device 2024-01: 0 reports for this device; peer average 2.52/device 2024-02: 1 reports for this device; peer average 1.78/device 2024-03: 1 reports for this device; peer average 2.15/device 2024-04: 0 reports for this device; peer average 2.11/device 2024-05: 0 reports for this device; peer average 2.17/device 2024-06: 0 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: 0 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: 1 reports for this device; peer average 1.89/device 2025-07: 0 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: 0 reports for this device; peer average 2.21/device 2026-03: 0 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 2 2.21 2022-08 2 2.3 2022-09 2 2.7 2022-10 2 3 2022-11 4 2.97 2022-12 0 4.54 2023-01 0 2.64 2023-02 2 2.75 2023-03 0 3.05 2023-04 2 2.91 2023-05 8 3.6 2023-06 0 2.95 2023-07 0 2.26 2023-08 0 2.19 2023-09 1 2.04 2023-10 1 2.25 2023-11 2 1.92 2023-12 0 2.43 2024-01 0 2.52 2024-02 1 1.78 2024-03 1 2.15 2024-04 0 2.11 2024-05 0 2.17 2024-06 0 2.29 2024-07 0 2.38 2024-08 0 2.18 2024-09 0 1.95 2024-10 0 2.23 2024-11 0 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 1 1.89 2025-07 0 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 0 2.21 2026-03 0 2.79 2026-04 0 2.18 2026-05 0 2.41 2026-06 0 2.17
Failure-mode summaryAI-generated
31 linked report narratives available — no AI summary generated yet.
Date Report # Type Narrative Link basis 2025-06-13 8030965-2025-05933 Injury Available exact di 2024-03-04 8030965-2024-03134 Malfunction Available exact di 2024-02-13 8030965-2024-02324 Malfunction Available exact di 2023-11-30 8030965-2023-15124 Malfunction Available exact di 2023-11-30 8030965-2023-15122 Malfunction Available exact di 2023-10-11 8030965-2023-12844 Malfunction Available exact di 2023-09-11 8030965-2023-11346 Malfunction Available exact di 2023-05-16 8030965-2023-06204 Malfunction Available exact di 2023-05-05 8030965-2023-05835 Malfunction Available exact di 2023-05-05 8030965-2023-05834 Malfunction Available exact di 2023-05-05 8030965-2023-05833 Malfunction Available exact di 2023-04-05 8030965-2023-04153 Injury Available exact di 2023-02-21 8030965-2023-02047 Injury Available exact di 2022-11-16 8030965-2022-09935 Injury Available exact di 2022-11-16 8030965-2022-09929 Malfunction Available exact di
Showing the most recent 19 of 31 linked reports.
Showing 1–15 of 19 ‹ Prev Next ›
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.