PROCOTYL · 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.

32 linked reportsInjury 32

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	3.32
2019-02	0	2.85
2019-03	0	3.29
2019-04	0	3.04
2019-05	0	2.32
2019-06	0	2
2019-07	0	1.96
2019-08	0	2.36
2019-09	0	2.66
2019-10	0	2.96
2019-11	0	2.47
2019-12	0	2.82
2020-01	0	3.31
2020-02	0	2.83
2020-03	3	3.61
2020-04	0	2.56
2020-05	0	2.44
2020-06	0	2.36
2020-07	0	2.82
2020-08	0	2.3
2020-09	0	2.95
2020-10	0	2.92
2020-11	3	2.64
2020-12	0	2.63
2021-01	0	2.79
2021-02	0	2.32
2021-03	3	2.31
2021-04	0	2.35
2021-05	0	2.23
2021-06	0	2.8
2021-07	3	2.65
2021-08	0	2.71
2021-09	3	2.78
2021-10	0	2.48
2021-11	0	2.34
2021-12	0	2.62
2022-01	0	2.39
2022-02	0	2.25
2022-03	0	2.54
2022-04	0	2.4
2022-05	0	2.42
2022-06	0	2.54
2022-07	0	2.37
2022-08	0	2.43
2022-09	0	2.47
2022-10	3	2.44
2022-11	0	2.52
2022-12	0	2.56
2023-01	0	2.65
2023-02	0	2.47
2023-03	3	2.74
2023-04	0	2.58
2023-05	0	2.46
2023-06	3	2.54
2023-07	0	2.32
2023-08	0	2.11
2023-09	0	2.09
2023-10	0	1.86
2023-11	0	1.79
2023-12	0	1.91
2024-01	0	1.89
2024-02	0	2.28
2024-03	0	2.07
2024-04	0	1.92
2024-05	0	2.2
2024-06	0	2.04
2024-07	0	1.86
2024-08	0	2.02
2024-09	0	2.19
2024-10	0	1.94
2024-11	0	2
2024-12	3	1.69
2025-01	3	2.18
2025-02	0	1.66
2025-03	0	1.88
2025-04	2	1.93
2025-05	0	1.93
2025-06	0	1.97
2025-07	0	1.96
2025-08	0	1.9
2025-09	0	1.82
2025-10	0	1.83
2025-11	0	1.88
2025-12	0	2
2026-01	0	2.06
2026-02	0	1.78
2026-03	0	2.01
2026-04	0	2.03
2026-05	0	1.84
2026-06	0	1.87

This device (reports/month)Average device in LPH, LZO (reports/device/month)

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2025-04-10	3010536692-2025-00162	Injury	Available	catalog number
2025-01-23	3010536692-2025-00013	Injury	Available	catalog number
2024-12-11	3010536692-2024-00494	Injury	Available	catalog number
2023-06-01	3010536692-2023-00102	Injury	Available	catalog number
2023-03-29	3010536692-2023-00043	Injury	Available	catalog number
2022-10-19	3010536692-2022-00369	Injury	Available	catalog number
2021-09-01	3010536692-2021-00486	Injury	Available	catalog number
2021-07-07	3010536692-2021-00366	Injury	Available	catalog number
2021-03-12	3010536692-2021-00151	Injury	Available	catalog number
2020-11-27	3010536692-2020-00714	Injury	Available	catalog number
2020-03-23	3010536692-2020-00261	Injury	Available	catalog number

Showing the most recent 11 of 32 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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