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.

6 linked reportsMalfunction 6

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	3.25
2019-02	0	4
2019-03	0	1.5
2019-04	0	3
2019-05	0	2.4
2019-06	0	2
2019-07	0	3.33
2019-08	0	3.83
2019-09	0	2.5
2019-10	0	3.17
2019-11	0	3
2019-12	0	3.4
2020-01	0	2.78
2020-02	0	2.17
2020-03	0	3.67
2020-04	0	3.33
2020-05	0	3
2020-06	0	4.78
2020-07	0	35
2020-08	0	20
2020-09	0	21
2020-10	0	13.6
2020-11	0	47.5
2020-12	0	9.88
2021-01	0	9.14
2021-02	0	14.33
2021-03	0	14.25
2021-04	0	11.09
2021-05	0	12
2021-06	0	6
2021-07	0	1.63
2021-08	0	1
2021-09	0	1
2021-10	0	1.25
2021-11	0	1.64
2021-12	0	1.33
2022-01	0	1.6
2022-02	0	6.6
2022-03	0	1.86
2022-04	0	1.67
2022-05	0	1.4
2022-06	0	2.14
2022-07	0	1.29
2022-08	0	1.09
2022-09	0	2.17
2022-10	0	1.64
2022-11	0	1.5
2022-12	0	1.54
2023-01	0	2
2023-02	0	2
2023-03	0	2
2023-04	0	1.26
2023-05	2	2.14
2023-06	4	2.75
2023-07	0	1.5
2023-08	0	1.57
2023-09	0	1.36
2023-10	0	1.83
2023-11	0	1.44
2023-12	0	1.7
2024-01	0	1.92
2024-02	0	2.89
2024-03	0	1.73
2024-04	0	2.33
2024-05	0	2.22
2024-06	0	2.57
2024-07	0	2.31
2024-08	0	4.25
2024-09	0	2.13
2024-10	0	3.42
2024-11	0	3.71
2024-12	0	2.57
2025-01	0	2
2025-02	0	3.58
2025-03	0	5.86
2025-04	0	1.75
2025-05	0	1.8
2025-06	0	2.13
2025-07	0	1.61
2025-08	0	1.75
2025-09	0	1
2025-10	0	2
2025-11	0	2
2025-12	0	1.1
2026-01	0	2.2
2026-02	0	1.5
2026-03	0	2.43
2026-04	0	1.79
2026-05	0	2.17
2026-06	0	1.5

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

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2023-06-23	3007143268-2023-00024	Malfunction	Available	exact di
2023-06-20	3007143268-2023-00023	Malfunction	Available	exact di
2023-05-24	3007143268-2023-00018	Malfunction	Available	exact di

Showing the most recent 3 of 6 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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