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.

35 linked reportsInjury 31Malfunction 4

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	2	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	0	3.38
2019-09	0	3.25
2019-10	0	4.64
2019-11	0	3.33
2019-12	0	2.33
2020-01	0	3.91
2020-02	2	2.44
2020-03	0	4.27
2020-04	1	1.9
2020-05	0	1.75
2020-06	4	3.57
2020-07	5	4.45
2020-08	2	2.82
2020-09	0	2.33
2020-10	4	2.67
2020-11	2	3.11
2020-12	0	3.4
2021-01	4	3.57
2021-02	0	2.89
2021-03	1	2
2021-04	2	3
2021-05	1	2
2021-06	3	2.55
2021-07	1	2.57
2021-08	1	1.82
2021-09	0	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

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2021-08-26	2031049-2021-00058	Malfunction	Available	exact di
2021-07-28	2031049-2021-00053	Injury	Available	exact di
2021-06-14	2031049-2021-00040	Injury	Available	exact di
2021-06-09	2031049-2021-00037	Injury	Available	exact di
2021-05-25	2031049-2021-00032	Malfunction	Available	exact di
2021-04-15	2031049-2021-00023	Injury	Available	exact di
2021-03-09	2031049-2021-00015	Injury	Available	exact di
2021-01-19	2031049-2021-00007	Injury	Available	exact di
2021-01-13	2031049-2021-00003	Injury	Available	exact di
2020-11-12	2031049-2020-00092	Injury	Available	exact di
2020-10-20	2031049-2020-00086	Injury	Available	exact di
2020-10-07	2031049-2020-00084	Malfunction	Available	exact di
2020-08-20	2031049-2020-00075	Injury	Available	exact di
2020-07-30	2031049-2020-00071	Injury	Available	exact di
2020-07-28	2031049-2020-00067	Injury	Available	exact di

Showing the most recent 24 of 35 linked reports.

Showing 1–15 of 24

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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