10886982274519 · recalls, adverse events, clearances

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.

24 linked reportsMalfunction 22Injury 2

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	1.48
2019-02	0	1.46
2019-03	0	1.35
2019-04	0	2
2019-05	0	1.33
2019-06	0	1.62
2019-07	0	2.13
2019-08	0	1.62
2019-09	0	1.45
2019-10	0	1.25
2019-11	0	1.33
2019-12	0	1.35
2020-01	0	1.6
2020-02	0	2.41
2020-03	0	1.43
2020-04	0	1.5
2020-05	0	1
2020-06	0	1.96
2020-07	0	1.5
2020-08	0	2.08
2020-09	0	2.38
2020-10	0	2.43
2020-11	0	1.72
2020-12	0	2.23
2021-01	1	1.6
2021-02	0	2.68
2021-03	0	2.64
2021-04	4	2.51
2021-05	0	2.82
2021-06	0	1.95
2021-07	0	1.71
2021-08	1	1.62
2021-09	0	1.76
2021-10	0	1.52
2021-11	1	2.83
2021-12	0	1.63
2022-01	2	2
2022-02	0	2.71
2022-03	0	2.12
2022-04	0	2.33
2022-05	0	4.67
2022-06	0	2.31
2022-07	0	2.1
2022-08	1	2.08
2022-09	0	2.52
2022-10	0	3
2022-11	0	3.44
2022-12	0	2.44
2023-01	0	2.92
2023-02	0	2.15
2023-03	2	2.15
2023-04	0	2.31
2023-05	1	3.16
2023-06	0	2.14
2023-07	0	2.17
2023-08	1	1.46
2023-09	0	2.25
2023-10	0	1.2
2023-11	0	1.25
2023-12	0	1.33
2024-01	0	1.2
2024-02	0	2.17
2024-03	0	1.35
2024-04	0	1.83
2024-05	0	1.43
2024-06	1	1.45
2024-07	0	1.1
2024-08	0	1.64
2024-09	0	1.25
2024-10	0	2
2024-11	1	1.67
2024-12	0	4.25
2025-01	1	1.29
2025-02	0	1.62
2025-03	1	1.25
2025-04	0	2
2025-05	0	1.44
2025-06	0	1.26
2025-07	1	1.73
2025-08	3	1.24
2025-09	0	1.54
2025-10	0	2.56
2025-11	0	1.86
2025-12	0	1.8
2026-01	1	1.57
2026-02	0	1.22
2026-03	0	1.25
2026-04	0	1.5
2026-05	0	3.33
2026-06	1	1.4

This device (reports/month)Average device in KTT (reports/device/month)

Failure-mode summaryAI-generated

24 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2026-06-17	8030965-2026-06296	Malfunction	Available	exact di
2026-01-16	8030965-2026-00608	Malfunction	Available	exact di
2025-08-18	8030965-2025-08543	Malfunction	Available	exact di
2025-08-04	8030965-2025-07956	Malfunction	Available	exact di
2025-08-04	8030965-2025-07997	Malfunction	Available	exact di
2025-07-29	8030965-2025-07716	Malfunction	Available	exact di
2025-03-10	8030965-2025-02307	Injury	Available	exact di
2025-01-10	8030965-2025-00397	Malfunction	Available	exact di
2024-11-04	8030965-2024-13560	Malfunction	Available	exact di
2024-06-24	8030965-2024-07817	Malfunction	Available	exact di
2023-08-01	8030965-2023-09580	Malfunction	Available	exact di
2023-05-03	8030965-2023-05634	Malfunction	Available	exact di
2023-03-08	8030965-2023-02847	Malfunction	Available	exact di
2022-08-02	8030965-2022-05485	Injury	Available	exact di
2022-01-13	8030965-2022-00313	Malfunction	Available	exact di

Showing the most recent 22 of 24 linked reports.

Showing 1–15 of 22

Regulatory clearances

Predicate lineage

K172872

Cited as predicate by: K182154

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

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

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