10886982210449 · 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.

4 linked reportsMalfunction 4

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	1.43
2019-02	0	1.44
2019-03	0	1.56
2019-04	0	1.54
2019-05	0	1.34
2019-06	0	1.58
2019-07	0	1.7
2019-08	0	1.69
2019-09	0	1.41
2019-10	0	1.38
2019-11	0	1.58
2019-12	0	1.47
2020-01	0	1.55
2020-02	0	1.73
2020-03	0	1.43
2020-04	0	1.81
2020-05	0	1.69
2020-06	0	2.11
2020-07	0	2.17
2020-08	0	2.83
2020-09	0	2.17
2020-10	0	2.49
2020-11	0	2.89
2020-12	0	3.15
2021-01	0	2.69
2021-02	0	2.99
2021-03	0	3.13
2021-04	0	3.22
2021-05	0	3.91
2021-06	0	2.82
2021-07	0	2.29
2021-08	0	1.95
2021-09	0	2.17
2021-10	0	1.69
2021-11	0	3.28
2021-12	0	2.23
2022-01	0	2.79
2022-02	0	2.19
2022-03	0	2.24
2022-04	0	2.35
2022-05	0	2.36
2022-06	0	2.22
2022-07	0	1.83
2022-08	0	1.94
2022-09	0	2.34
2022-10	0	2.51
2022-11	0	2.64
2022-12	0	2.18
2023-01	0	2.28
2023-02	0	2.18
2023-03	0	2.46
2023-04	0	2.32
2023-05	0	2.73
2023-06	0	2.49
2023-07	0	1.99
2023-08	0	1.62
2023-09	0	1.58
2023-10	0	1.41
2023-11	0	1.46
2023-12	0	1.48
2024-01	0	1.51
2024-02	0	1.49
2024-03	0	1.64
2024-04	0	1.43
2024-05	0	1.63
2024-06	0	1.67
2024-07	0	1.4
2024-08	0	1.89
2024-09	0	2.02
2024-10	0	1.68
2024-11	0	1.55
2024-12	0	1.74
2025-01	0	1.62
2025-02	0	1.53
2025-03	0	1.5
2025-04	0	1.58
2025-05	0	1.51
2025-06	0	1.41
2025-07	0	1.57
2025-08	0	1.42
2025-09	2	1.4
2025-10	0	1.75
2025-11	2	1.76
2025-12	0	1.77
2026-01	0	1.8
2026-02	0	1.45
2026-03	0	1.69
2026-04	0	1.6
2026-05	0	1.84
2026-06	0	1.57

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

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2025-11-21	8030965-2025-11758	Malfunction	Available	exact di
2025-11-21	8030965-2025-11756	Malfunction	Available	exact di
2025-09-15	8030965-2025-09342	Malfunction	Available	exact di
2025-09-15	8030965-2025-09339	Malfunction	Available	exact di

Regulatory clearances

Predicate lineage

K000684

Cited as predicate by: K101536, K103002, K103513, K111540, K112583, K112663, K113652, K113760, K120651, K120717, K120807, K120854, K121601, K122936, K130009, K133452, K133541, K140216, K140431, K140607, K141680, K143061, K150561, K152289, K152732, K153374, K153716, K160553, K161048, K161894, K162078, K163044, K163361, K163383, K170727, K170887, K171285, K181035, K181587, K191118, K191793, K193554, K193633, K193639, K201321, K223150, K230623, K231213, K233665, K233873, K243308, K243469, K260390

K103002

Cited as predicate by: K160553, K252016

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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