Reportedly, the theading on the tab used to secure the leksell frame to the leksell frame adaptor has been damaged, and the screw cannot be screwed entirely.Despite several attempts to retrieve the leksell frame adaptor, the device was not returned.However, from the pictures provided, it can be confirmed that the threading is worn and that it might compromise proper screw operation.The most probable root causes are: an excessive force was applied to the screw when screwing and this caused the damages to the thread; the thread is damaged because of repetitive screwing, which would be a normal wear and tear of the part.However, none of this hypotheses can be confirmed as the part was not returned.The event described in the complaint is confirmed.Corrected data: b4 date of this report.G4 date received by manufacturer.G5 pma/510(k) number.H2 if follow-up, what type.H3 device evaluated by manufacturer.H6 event problem and evaluation codes.
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