WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREWS: MATRIXWAVE; SCREW, FIXATION, INTRAOSSEOUS
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Non-union Bone Fracture (2369)
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Event Type
Injury
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Event Description
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It was reported that on (b)(6) 2021, patient underwent revision due to non-united fracture through inferolateral left maxilla sinus wall.Operative reports structural injury due to compression of the infraorbital foramen.After the surgery, the patient is experiencing numbness, nerve damage, vision problems and face asymmetry.There are no plans to do a revision surgery.This report is for an unknown matrixwave screw.This is report 7 of 17 for pc-(b)(4).
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Manufacturer Narrative
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This report is for an unknown matrixwave screw/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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