The device was returned, the investigation has been completed and the results are as follows: dhr results.The dhr was reviewed for case #(b)(4) and there was no evidence discovered to indicate that a product defect or non-conformity contributed to the issue.Material lot information was not obtainable.Sufficient due diligence was put forth in an effort to identify the lot number.Stock product reviewed results.No stock product was available for review since the device was fabricated per physician's prescription only.Investigation methods/results.Complaint investigator reviewed the returned device.A lower splint was returned in the original case.The results were summarized: roughness - the flange was smooth; internal/external surfaces were smooth.Crack - no major crack was found.Delamination - layers were intact and did not separate.Discoloration - the device was not discolored.General cleanliness - the returned device appeared to be clean, free of debris or foreign particles.The returned device was visually inspected, and no defect or abnormality was observed.There was no evidence found to indicate that the reported issue was caused by the device itself.Root cause.A root cause for this complaint cannot be explicitly determined.Ifu 12383 rev 3.0 (comfort3d bite splint instruction for use) states "brush and floss your teeth before use.Rinse mouth well with clean water before inserting the device.If patient uses mouthwash, all traces of mouthwash should be removed by thoroughly rinsing out mouth with water.Rinse bite splint well with clean, cool water before and after use.Clean bite splint with clean, cool water only and let air dry." ifu provides warning "do not clean or soak in mouthwash; do not use denture cleanser, hot water, alcohol, hydrogen peroxide; do not place in direct sunlight".It is possible that reactions could be caused by mouthwash, toothpaste, or soaking material.However, the provider is not sure how the patient handled and cared for the device.Rpt 012620 rev.1.0 (comfort3d bite splint verification), confirms that the resin material meets the acceptance criteria for biocompatibility (cytotoxicity, irritation, and sensitization) and mechanical properties (flexural strength, flexural modulus, sorption, solubility, and free monomer extraction).
|
Additional data: a6, b2, h6 (type of investigation code).Corrected data: d1, h6 (health effect - impact code).Note: h4 was inadvertently added in the initial report.Insufficient device information was provided to obtain the manufacturing date.Capa 23-006.Manufacturer reference: (b)(4).
|