DELTA XTEND · 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.

14 linked reportsInjury 14

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	1.81
2019-02	0	1.74
2019-03	0	1.72
2019-04	0	1.79
2019-05	0	2.02
2019-06	0	1.86
2019-07	0	1.58
2019-08	0	2.14
2019-09	0	1.65
2019-10	0	1.82
2019-11	0	1.7
2019-12	0	1.74
2020-01	0	1.98
2020-02	0	2.11
2020-03	0	1.99
2020-04	0	1.77
2020-05	1	1.65
2020-06	0	1.92
2020-07	0	2.16
2020-08	0	1.79
2020-09	0	1.97
2020-10	0	2.11
2020-11	0	1.88
2020-12	0	1.84
2021-01	0	2.11
2021-02	0	2.02
2021-03	1	2.13
2021-04	1	2.02
2021-05	0	1.96
2021-06	0	1.8
2021-07	1	2.05
2021-08	0	2.2
2021-09	0	1.94
2021-10	0	2.13
2021-11	0	2.1
2021-12	1	2.39
2022-01	0	2.54
2022-02	0	2.33
2022-03	0	2.38
2022-04	0	2.39
2022-05	2	2.1
2022-06	1	2.2
2022-07	0	2.23
2022-08	0	2.2
2022-09	0	2.01
2022-10	0	2.06
2022-11	0	2.07
2022-12	0	2.01
2023-01	0	1.84
2023-02	0	1.96
2023-03	0	2.05
2023-04	1	2.17
2023-05	0	2.1
2023-06	1	2.27
2023-07	0	2.05
2023-08	0	1.7
2023-09	0	1.52
2023-10	0	1.62
2023-11	0	1.63
2023-12	0	1.43
2024-01	0	1.79
2024-02	0	1.78
2024-03	0	1.66
2024-04	1	1.83
2024-05	1	1.64
2024-06	0	1.88
2024-07	0	1.56
2024-08	0	1.71
2024-09	0	1.67
2024-10	1	1.69
2024-11	1	1.58
2024-12	0	1.6
2025-01	0	1.7
2025-02	0	1.6
2025-03	0	1.88
2025-04	0	1.68
2025-05	0	1.74
2025-06	0	1.87
2025-07	0	1.74
2025-08	0	1.58
2025-09	0	1.5
2025-10	0	1.63
2025-11	0	1.75
2025-12	0	2.15
2026-01	0	1.88
2026-02	0	1.83
2026-03	0	1.74
2026-04	0	1.72
2026-05	0	1.72
2026-06	0	1.77

This device (reports/month)Average device in HSD, KWS, PHX (reports/device/month)

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2024-11-21	1818910-2024-24351	Injury	Available	exact di
2024-10-14	1818910-2024-21516	Injury	Available	exact di
2024-05-23	1818910-2024-11443	Injury	Available	exact di
2024-04-29	1818910-2024-09383	Injury	Available	exact di
2023-06-16	1818910-2023-12382	Injury	Available	exact di
2023-04-28	1818910-2023-08945	Injury	Available	exact di
2022-06-27	1818910-2022-11816	Injury	Available	exact di
2022-05-23	1818910-2022-09430	Injury	Available	exact di
2022-05-19	1818910-2022-09067	Injury	Available	exact di
2021-12-15	1818910-2021-25680	Injury	Available	exact di
2021-07-12	1818910-2021-14966	Injury	Available	exact di
2021-04-28	1818910-2021-09030	Injury	Available	exact di
2021-03-16	1818910-2021-05243	Injury	Available	exact di
2020-05-06	1818910-2020-11750	Injury	Available	exact di

Regulatory clearances

Predicate lineage

K071379

Cited as predicate by: K170452, K170748, K192448, K192855, K210167, K212737

K120174

Cited as predicate by: K170893, K172054, K183077, K190286, K192448, K192855, K193560, K203694, K210167, K210207, K212569, K212737, K220452, K230315, K231112, K233408, K241143, K242813, K260802

K192448

Cited as predicate by: K210167

K192855

Cited as predicate by: K203694, K211553

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
2024-07-04	NAI	No action indicated	DEPUY (IRELAND)	0
2015-01-08	NAI	No action indicated	DEPUY (IRELAND)	0
2012-01-26	VAI	Voluntary action indicated	DEPUY (IRELAND)	1
2011-02-03	NAI	No action indicated	DEPUY (IRELAND)	0

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