Product analysis: macroscopic and optical examination revealed thread crest and flank damage; this damage appears to have initiated at the start of the thread, and is consistent around the damaged portion of the thread.Functional evaluation with a sample mas found the implant unable to be fully engaged into the mas head.This type of damage is consistent with misalignment of the mas and set screw threads during construct assembly.If information is provided in the future, a supplemental report will be issued.
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It was reported that the patient underwent surgery at l4-iliac.Intra-op, the set screw could not be fixed in the screw.After two unsuccessful attempts to fix the set screws, the physician decided to switch the screws too.From physician's experience, he decided not to implant the set screws at all; and the procedure was completed.No patient complications were reported.
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