Concomitant medical products: cortical bone screw, 4x26mm; catalog#: 47-2486-126-40; lot#: 3073757.Cortical bone screw, 4x26mm; catalog#: 47-2486-126-40; lot#: 3076795.Therapy date: (b)(6) 2021.The manufacturer received x-rays and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2022-00187; 0009613350-2022-00177.
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This follow-up report is being submitted to relay additional and/or corrected information.The product was not returned for investigation.Therefore, visual and dimensional evaluation could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Devices are used for treatment.Based on the investigation it could be assumed that further possible contributing factors to the migration of the screw might be multifactorial related to either patient condition, behaviour or implantation procedure.If and to what extent any of these aspects may have influenced the migration of the screw remains unknown.In conclusion, as the cause may be multifactorial an exact root cause could not be identified for the migration of the screw.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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