Update: product code for the other two leading materials changed to sn353r and item name changed to tspace peek/xp/3d trial 5° 30x11.5x8mm.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2023-00037 (400585235 - (b)(6)), 9610612-2023-00038 (400585236 - (b)(6)), and 9610612-2023-00036 (400588773 - (b)(6)).
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Investigation results: no investigation method could be applied, because product was not provided for investigation.Device history review: without a provided lot number, the device quality and manufacturing records could not be reviewed.Explanation and rationale: due to the insufficient information, the fact that none of the products complained about is available for inspection / analysis and the fact that the problem described is caused by defective or damaged trial implants as well as a worn insertion instrument or incorrect handling both when coupling the trial implant and when insertion itself can be caused, a valid statistical evaluation cannot be carried out.Thus, neither of the two risk analyzes (trial implant / instrument) is applicable.Conclusion and preventive measures: based upon the investigation results, a clear root cause could not be determined.If the product is returned in the future, an investigation will again be performed at that time.Root cause cannot be finally concluded.Therefore the root cause specific risk cannot be identified.The potential risk determined during initial vigilance evaluation remains valid.Based upon the investigation results, a capa is not necessary.
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