Patient-Fitted TMJ Reconstructive Prosthesis System · 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.

63 linked reportsInjury 63

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	1.43
2019-02	0	1.38
2019-03	0	2
2019-04	0	3.25
2019-05	0	2.89
2019-06	0	2.13
2019-07	0	3
2019-08	3	3.38
2019-09	3	3.25
2019-10	0	4.64
2019-11	0	3.33
2019-12	0	2.33
2020-01	0	3.91
2020-02	0	2.44
2020-03	2	4.27
2020-04	1	1.9
2020-05	0	1.75
2020-06	4	3.57
2020-07	11	4.45
2020-08	3	2.82
2020-09	2	2.33
2020-10	0	2.67
2020-11	8	3.11
2020-12	7	3.4
2021-01	4	3.57
2021-02	0	2.89
2021-03	1	2
2021-04	7	3
2021-05	1	2
2021-06	2	2.55
2021-07	2	2.57
2021-08	1	1.82
2021-09	1	1.6
2021-10	0	1.5
2021-11	0	2
2021-12	0	1.2
2022-01	0	2.29
2022-02	0	1
2022-03	0	1
2022-04	0	1.5
2022-05	0	1
2022-06	0	2.25
2022-07	0	2.63
2022-08	0	1.67
2022-09	0	2
2022-10	0	1.33
2022-11	0	2
2022-12	0	2
2023-01	0	1.67
2023-02	0	1.5
2023-03	0	1.38
2023-04	0	2.67
2023-05	0	1.57
2023-06	0	3
2023-07	0	2
2023-08	0	2.64
2023-09	0	1.71
2023-10	0	2.82
2023-11	0	1.92
2023-12	0	1.43
2024-01	0	3.75
2024-02	0	1.63
2024-03	0	4.25
2024-04	0	2.6
2024-05	0	3.5
2024-06	0	3
2024-07	0	1.75
2024-08	0	2
2024-09	0	2.6
2024-10	0	1.75
2024-11	0	2
2024-12	0	4
2025-01	0	2
2025-02	0	2.83
2025-03	0	2
2025-04	0	3.5
2025-05	0	4
2025-06	0	3.33
2025-07	0	2.4
2025-08	0	1.5
2025-09	0	1.58
2025-10	0	1.5
2025-11	0	1.8
2025-12	0	7.25
2026-02	0	5
2026-03	0	1.5
2026-04	0	1
2026-05	0	3
2026-06	0	1.9

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

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2021-09-07	2031049-2021-00060	Injury	Available	exact di
2021-08-25	2031049-2021-00056	Injury	Available	model number
2021-07-13	2031049-2021-00046	Injury	Available	exact di
2021-07-08	2031049-2021-00045	Injury	Available	exact di
2021-06-22	2031049-2021-00043	Injury	Available	model number
2021-06-02	2031049-2021-00035	Injury	Available	exact di
2021-05-04	2031049-2021-00031	Injury	Available	exact di
2021-04-27	2031049-2021-00027	Injury	Available	exact di
2021-04-26	2031049-2021-00025	Injury	Available	exact di
2021-04-07	2031049-2021-00019	Injury	Available	exact di
2021-04-07	2031049-2021-00021	Injury	Available	exact di
2021-03-11	2031049-2021-00017	Injury	Available	model number
2021-01-28	2031049-2021-00010	Injury	Available	exact di
2021-01-18	2031049-2021-00006	Injury	Available	exact di
2020-12-21	2031049-2020-00106	Injury	Available	exact di

Showing the most recent 42 of 63 linked reports.

Showing 1–15 of 42

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2020-01-24	NAI	No action indicated	TMJ Solutions Inc	0
2015-04-02	VAI	Voluntary action indicated	TMJ Solutions Inc	1
2012-02-13	NAI	No action indicated	TMJ Solutions Inc	0

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