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.
No adverse-event reports are linked to this device.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2024-07-24 | Z-3264-2024 | Class II | Open, Classified | Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEODistribution: US Nationwide distribution in the state of MN. | 1 | code info di |
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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