10886982142757 · 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.

35 linked reportsMalfunction 35

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	3	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	25	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	0	2.21
2022-08	0	2.3
2022-09	0	2.7
2022-10	0	3
2022-11	0	2.97
2022-12	0	4.54
2023-01	0	2.64
2023-02	0	2.75
2023-03	0	3.05
2023-04	0	2.91
2023-05	0	3.6
2023-06	0	2.95
2023-07	0	2.26
2023-08	4	2.19
2023-09	0	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	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	2	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	0	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

This device (reports/month)Average device in HRS, HWC (reports/device/month)

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2024-09-19	8030965-2024-11770	Malfunction	Available	exact di
2024-09-19	8030965-2024-11769	Malfunction	Available	exact di
2023-12-21	8030965-2023-15983	Malfunction	Available	exact di
2023-08-23	8030965-2023-10636	Malfunction	Available	exact di
2023-08-23	8030965-2023-10633	Malfunction	Available	exact di
2023-08-18	8030965-2023-10429	Malfunction	Available	exact di
2023-08-18	8030965-2023-10428	Malfunction	Available	exact di
2021-09-30	2939274-2021-05818	Malfunction	Available	exact di
2021-09-30	8030965-2021-08174	Malfunction	Available	exact di
2021-09-30	2939274-2021-05819	Malfunction	Available	exact di
2021-09-30	2939274-2021-05817	Malfunction	Available	exact di
2021-09-30	2939274-2021-05840	Malfunction	Available	exact di
2021-09-30	2939274-2021-05823	Malfunction	Available	exact di
2021-09-30	2939274-2021-05839	Malfunction	Available	exact di
2021-09-30	2939274-2021-05831	Malfunction	Available	exact di

Showing 1–15 of 35

Regulatory clearances

Predicate lineage

K063049

Cited as predicate by: K100776, K103332, K110086, K111253, K113364, K121601, K122334, K123000, K132886, K133536, K140724, K142419, K143394, K150099, K160553, K163046, K163361, K171904, K180554, K182201, K190391, K190750, K190992, K191344, K191412, K201510, K201656, K211051, K212581, K221920, K223150, K232394, K233665, K242973, K252191, K254054

K102694

Cited as predicate by: K110125, K142419, K153034, K160553, K163046, K163361, K170705, K170843, K171320, K180310, K182650, K190391, K211324, K243308

K103243

Cited as predicate by: K123562, K160553, K221150

K112583

Cited as predicate by: K122489, K150099, K150561, K150981, K153374, K153638, K160553, K161616, K161894, K162124, K163383, K171320, K172383, K180541, K191793, K192745, K200062, K211051, K211435, K222282, K233665, K233873, K241815, K243469

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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