LCP · 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.

2 linked reportsInjury 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	1.94
2019-02	0	1.56
2019-03	0	1.88
2019-04	0	2.36
2019-05	0	1.69
2019-06	0	1.64
2019-07	0	1.68
2019-08	0	1.54
2019-09	0	1.66
2019-10	0	1.53
2019-11	0	1.8
2019-12	0	2
2020-01	0	2.19
2020-02	0	1.28
2020-03	0	1.64
2020-04	0	1.95
2020-05	0	1.79
2020-06	0	1.92
2020-07	0	1.93
2020-08	0	2.34
2020-09	0	2.75
2020-10	1	1.95
2020-11	0	2.34
2020-12	0	2.26
2021-01	0	1.79
2021-02	0	1.94
2021-03	0	2.13
2021-04	0	2.85
2021-05	0	2.64
2021-06	0	2.05
2021-07	0	2.28
2021-08	0	1.87
2021-09	0	2.04
2021-10	0	2.02
2021-11	0	2.05
2021-12	0	2.21
2022-01	0	2.88
2022-02	0	2
2022-03	0	1.65
2022-04	0	2.04
2022-05	0	1.96
2022-06	0	2.35
2022-07	0	2.26
2022-08	0	2.01
2022-09	0	2.39
2022-10	0	3
2022-11	0	2.93
2022-12	0	2.83
2023-01	0	2.51
2023-02	0	2.57
2023-03	0	2.98
2023-04	0	3.11
2023-05	0	4.19
2023-06	0	2.96
2023-07	0	2.23
2023-08	0	2.22
2023-09	0	2.08
2023-10	0	2.45
2023-11	0	2.03
2023-12	0	2.42
2024-01	0	2.06
2024-02	0	1.72
2024-03	0	1.82
2024-04	1	2.09
2024-05	0	1.95
2024-06	0	2.35
2024-07	0	2.23
2024-08	0	2.28
2024-09	0	1.66
2024-10	0	2.32
2024-11	0	1.61
2024-12	0	2.88
2025-01	0	1.62
2025-02	0	1.76
2025-03	0	2.68
2025-04	0	1.82
2025-05	0	2.08
2025-06	0	1.73
2025-07	0	2.09
2025-08	0	2.1
2025-09	0	1.75
2025-10	0	2.08
2025-11	0	1.92
2025-12	0	2.46
2026-01	0	1.7
2026-02	0	2
2026-03	0	3.1
2026-04	0	2.2
2026-05	0	2.03
2026-06	0	1.84

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

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2024-04-11	8030965-2024-04853	Injury	Available	exact di
2020-10-15	2939274-2020-04688	Injury	Available	exact di

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

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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