Prodisc L · 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.

28 linked reportsInjury 20Malfunction 8

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	1.5
2019-02	0	1
2019-03	0	1.33
2019-04	0	1
2019-05	0	2.2
2019-06	0	1.96
2019-07	0	1.89
2019-09	0	1
2019-10	0	3.25
2019-12	0	2.5
2020-01	0	1.83
2020-03	0	2.67
2020-04	0	1.5
2020-05	0	3
2020-06	0	1.5
2020-07	0	4.67
2020-08	0	3.11
2020-09	2	1.5
2020-10	1	2.36
2020-11	0	1.6
2020-12	0	1.5
2021-01	0	3.33
2021-02	0	1.5
2021-03	4	2.56
2021-04	0	3.33
2021-05	0	1.67
2021-06	2	2.29
2021-07	1	1.67
2021-08	2	1.83
2021-09	2	1.6
2021-11	0	3.82
2021-12	0	3
2022-01	0	3.83
2022-02	2	1.5
2022-03	4	2.5
2022-04	0	1.2
2022-05	0	1.67
2022-06	0	2.25
2022-07	0	1.5
2022-08	0	2.67
2022-09	0	1.33
2022-10	0	1.25
2022-11	0	1.6
2022-12	0	1.67
2023-01	0	4.6
2023-02	0	1.2
2023-03	1	1.43
2023-04	0	1.33
2023-05	0	1.9
2023-06	0	1.25
2023-07	0	1.5
2023-08	0	1.8
2023-09	0	1.29
2023-10	1	1.3
2023-11	0	1.75
2023-12	0	1.25
2024-01	0	2.22
2024-02	4	2.22
2024-03	0	1.68
2024-04	0	1.22
2024-05	0	2.89
2024-06	0	2.83
2024-07	0	1.6
2024-08	0	1.7
2024-09	0	1.89
2024-10	0	1.45
2024-11	0	1.88
2024-12	0	2.1
2025-01	2	2.32
2025-02	0	2.17
2025-03	0	2
2025-04	0	1
2025-05	0	1.25
2025-06	0	1.8
2025-07	0	1.8
2025-08	0	2.15
2025-09	0	1.93
2025-10	0	1.53
2025-11	0	3
2025-12	0	1.8
2026-01	0	1.73
2026-02	0	1.44
2026-03	0	1.88
2026-04	0	1.93
2026-05	0	2.38
2026-06	0	1.75

This device (reports/month)Average device in MJO (reports/device/month)

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2025-01-30	3007494564-2025-00018	Injury	Available	exact di
2024-02-15	3007494564-2024-00017	Injury	Available	exact di
2024-02-15	3007494564-2024-00014	Injury	Available	exact di
2023-10-03	3007494564-2023-00052	Injury	Available	exact di
2023-03-08	3007494564-2023-00009	Malfunction	Available	model number
2022-03-17	3007494564-2022-00007	Injury	Available	exact di
2022-03-17	3007494564-2022-00010	Injury	Available	exact di
2022-02-04	3007494564-2022-00002	Injury	Available	exact di
2021-09-01	3007494564-2021-00076	Injury	Available	exact di
2021-08-18	3007494564-2021-00073	Malfunction	Available	exact di
2021-07-23	3007494564-2021-00063	Malfunction	Available	exact di
2021-06-04	3007494564-2021-00046	Malfunction	Available	exact di
2021-03-29	3007494564-2021-00023	Malfunction	Available	exact di
2021-03-12	3007494564-2021-00017	Injury	Available	exact di
2020-10-15	3007494564-2020-00045	Injury	Available	model number

Showing the most recent 16 of 28 linked reports.

Showing 1–15 of 16

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility
2013-01-15	NAI	No action indicated	Centinel Spine, Inc.
2013-01-15	NAI	No action indicated	Centinel Spine, Inc.
2010-05-19	NAI	No action indicated	Centinel Spine, Inc.
2010-05-19	NAI	No action indicated	Centinel Spine, Inc.

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