GUARDIAN® · 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.

38 linked reportsInjury 35Malfunction 3

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	3.2
2019-02	0	2.73
2019-03	0	2.73
2019-04	0	2.64
2019-05	0	2.14
2019-06	0	1.88
2019-07	3	2.1
2019-08	0	2.11
2019-09	0	2.34
2019-10	0	2.35
2019-11	0	1.93
2019-12	3	2.38
2020-01	0	2.54
2020-02	0	2.53
2020-03	6	3.26
2020-04	0	2.33
2020-05	3	2.67
2020-06	3	1.89
2020-07	0	2.42
2020-08	0	1.86
2020-09	0	2.21
2020-10	3	2.56
2020-11	0	2.17
2020-12	0	2.11
2021-01	0	2.12
2021-02	0	1.93
2021-03	3	2.02
2021-04	0	1.94
2021-05	0	2.07
2021-06	0	2.35
2021-07	3	2.38
2021-08	3	2
2021-09	0	2.26
2021-10	0	2.02
2021-11	0	2.38
2021-12	0	2.49
2022-01	0	2.04
2022-02	0	2.76
2022-03	0	1.86
2022-04	0	2.3
2022-05	0	2
2022-06	0	2.11
2022-07	0	2
2022-08	0	2.16
2022-09	0	1.98
2022-10	0	2.05
2022-11	0	2.31
2022-12	0	2.22
2023-01	0	1.71
2023-02	0	1.89
2023-03	0	2.08
2023-04	0	1.93
2023-05	0	2.23
2023-06	0	2.28
2023-07	0	2.11
2023-08	0	2.18
2023-09	0	2.16
2023-10	0	1.47
2023-11	0	1.55
2023-12	3	1.57
2024-01	0	1.69
2024-02	0	1.81
2024-03	0	1.96
2024-04	0	1.64
2024-05	0	2.19
2024-06	0	1.84
2024-07	0	1.69
2024-08	0	1.78
2024-09	0	2.09
2024-10	0	1.71
2024-11	0	1.55
2024-12	0	1.52
2025-01	0	1.55
2025-02	0	1.45
2025-03	0	1.61
2025-04	0	1.76
2025-05	0	1.52
2025-06	0	1.73
2025-07	0	1.69
2025-08	0	1.63
2025-09	2	1.91
2025-10	0	1.74
2025-11	0	2.04
2025-12	0	1.96
2026-01	0	2.23
2026-02	0	1.7
2026-03	0	2.33
2026-04	0	1.77
2026-05	0	2.02
2026-06	3	1.65

This device (reports/month)Average device in JDI, KRO (reports/device/month)

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2026-06-15	3010536692-2026-00222	Injury	Available	catalog number
2025-09-23	3010536692-2025-00339	Injury	Available	catalog number
2023-12-15	3010536692-2023-00226	Injury	Available	catalog number
2021-08-06	3010536692-2021-00436	Injury	Available	catalog number
2021-07-07	3010536692-2021-00355	Injury	Available	catalog number
2021-03-02	3010536692-2021-00129	Injury	Available	catalog number
2020-10-09	3010536692-2020-00638	Injury	Available	catalog number
2020-06-26	3010536692-2020-00436	Injury	Available	catalog number
2020-05-19	3010536692-2020-00361	Injury	Available	catalog number
2020-03-31	3010536692-2020-00306	Malfunction	Available	catalog number
2020-03-16	3010536692-2020-00240	Injury	Available	catalog number
2019-12-11	3010536692-2019-01177	Injury	Available	catalog number
2019-07-31	3010536692-2019-00927	Injury	Available	catalog number

Showing the most recent 13 of 38 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2023-02-08	NAI	No action indicated	MicroPort Orthopedics Inc.	0
2023-02-08	NAI	No action indicated	MicroPort Orthopedics Inc.	0
2018-06-29	VAI	Voluntary action indicated	MicroPort Orthopedics Inc.	2
2018-06-29	VAI	Voluntary action indicated	MicroPort Orthopedics Inc.	2
2015-08-19	VAI	Voluntary action indicated	MicroPort Orthopedics Inc.	5
2015-08-19	VAI	Voluntary action indicated	MicroPort Orthopedics Inc.	5
2015-06-17	WL	Warning Letter	MicroPort Orthopedics Inc.	—
2015-06-17	WL	Warning Letter	MicroPort Orthopedics Inc.	—

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