RAYNHAM SYNTHES USA PRODUCTS LLC UNK - BIOMATERIAL - CEMENT DELIVERY DEVICES: NORIAN: TRAUMA; FILLER, CALCIUM SULFATE PREFORMED PELLETS
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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510k: this report is for an unknown biomaterial - cement delivery devices: norian: trauma /unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.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.(b)(4).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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Event Description
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It was reported that on an unknown date, the patient returned to surgery for removal of vivigen and debridement in distal tibia due to infection and skin breakdown.The patients received the implant on (b)(6) 2020.Procedure and patient outcome are unknown.Concomitant devices reported: bone graft harvesting (part number unknown, lot unknown, quantity 1), nails: tibial (part number unknown, lot unknown, quantity 1).This report involves one (1) unknown biomaterial - cement delivery devices: norian: trauma.This is report 3 of 3 for (b)(4).
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Search Alerts/Recalls
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