No x-rays or images of the reported event could be provided, thus the non-union could not be confirmed.As stated in the event description, the non-union has been reported about 12 weeks after initial procedure.The screws appeared to be stable and were removed during revision surgery and fixation has been placed.Prior to the reported event, the patient has missed several follow-up appointments.The sales rep also mentioned in an e-mail that the patient is non-compliant to post-operative care instructions.Based on statistical evaluation, there is no indication for an incorrectly working product or any systematic design, material or manufacturing related issue.Therefore, no further corrective and / or preventive actions are deemed necessary at this time.The complaint is added to the complaint trend.Should further information be available, the investigation will be re-evaluated.Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.H3: device is not available for evaluation.If additional information is received it will be reported on a supplemental report.
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