Trumpf Medical · 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.

23 linked reportsMalfunction 23

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
2019-02	0	1
2019-03	0	1.5
2019-04	0	1
2019-05	0	2
2019-06	0	1.5
2019-07	0	3
2019-08	0	1
2019-09	0	2.5
2019-11	0	5
2019-12	0	2.5
2020-01	0	2.5
2020-02	0	1
2020-03	0	2
2020-04	0	3
2020-05	0	4
2020-06	0	7.67
2020-07	0	35
2020-08	0	28
2020-09	0	38
2020-10	0	28
2020-11	0	47.5
2020-12	0	16.75
2021-01	0	10.5
2021-02	0	23.2
2021-03	0	20.8
2021-04	0	16.67
2021-05	0	13.83
2021-06	1	7.5
2021-07	0	1.4
2021-08	0	1
2021-09	1	1
2021-10	0	1
2021-11	0	1.4
2021-12	0	1.4
2022-01	0	1
2022-02	0	6.6
2022-03	0	2.33
2022-04	0	2
2022-05	0	1.67
2022-06	0	2.75
2022-07	0	1.4
2022-08	0	1
2022-09	0	2.75
2022-10	0	2
2022-11	0	1.67
2022-12	0	1.56
2023-01	0	3
2023-02	0	2
2023-03	2	1.86
2023-04	0	1.18
2023-05	0	2.23
2023-06	0	2.78
2023-07	0	2
2023-08	0	1.75
2023-09	0	1.5
2023-10	0	2
2023-11	0	1.2
2023-12	0	1.43
2024-01	0	2.25
2024-02	3	2.86
2024-03	1	1.38
2024-04	0	2
2024-05	2	2.08
2024-06	0	2.33
2024-07	1	1
2024-08	3	3.29
2024-09	3	1.88
2024-10	0	3
2024-11	1	3.42
2024-12	0	2.5
2025-01	0	2
2025-02	1	3.6
2025-03	1	5.25
2025-04	0	1
2025-05	0	1.33
2025-06	0	2.2
2025-07	0	1.54
2025-08	0	1.64
2025-09	0	1
2025-10	0	1.67
2025-11	1	1.62
2025-12	1	1.13
2026-01	0	1.5
2026-02	0	1.57
2026-03	0	2
2026-04	1	1.46
2026-05	0	1.33
2026-06	0	1.13

This device (reports/month)Average device in GDC, KXJ (reports/device/month)

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2026-04-21	3007143268-2026-00028	Malfunction	Available	exact di
2025-12-22	3007143268-2025-00093	Malfunction	Available	exact di
2025-11-21	3007143268-2025-00085	Malfunction	Available	exact di
2025-03-04	3007143268-2025-00019	Malfunction	Available	model number
2025-02-11	3007143268-2025-00006	Malfunction	Available	model number
2024-11-26	3007143268-2024-00071	Malfunction	Available	model number
2024-09-27	3007143268-2024-00051	Malfunction	Available	model number
2024-09-19	3007143268-2024-00046	Malfunction	Available	model number
2024-09-16	3007143268-2024-00045	Malfunction	Available	model number
2024-08-27	3007143268-2024-00039	Malfunction	Available	model number
2024-08-09	3007143268-2024-00034	Malfunction	Available	exact di
2024-07-08	3007143268-2024-00029	Malfunction	Available	model number
2024-05-07	3007143268-2024-00018	Malfunction	Available	model number
2024-05-02	3007143268-2024-00017	Malfunction	Available	model number
2024-03-07	3007143268-2024-00011	Malfunction	Available	model number

Showing the most recent 20 of 23 linked reports.

Showing 1–15 of 20

Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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