One certain gold-tite hexed screw (iunihg) was not returned for investigation.Therefore, visual evaluation could not be performed.The investigation was performed using applicable instructions for use and risk files to address reported event.Functional testing could not be performed since the product was not returned.Pre-existing condition, tooth location and the duration of placement are unknown due to limited information provided by customer.X-ray or picture images were not provided.Dhr review could not be performed as the lot number associated with the reported device was not available.However, zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products within specifications.A year-long complaint history review by item number (iunihg) was performed for similar events and no complaint about nonconforming products was identified.Monthly post market trending was reviewed and there were no actionable events or corrective actions for the reported event (functional: loosening) or product (iunihg).Therefore, based on the available information, device malfunction and the reported events could not be verified as the exact details of event were nonverifiable and the product was not returned.Based on the investigation, risk review and ifu, the most likely cause determined from the investigation is clinician failure to torque screw to specification or parafunctional habits of the patient over the implantation period.No further investigation or immediate capa/hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.
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