Patient information: unknown.Occupation - other: sales representative.Product evaluation - product evaluation was not possible as explanted product was not returned to the manufacturer.Review of device history record found (b)(4) pieces of this lot were released for distribution on 3/26/2018 with no deviation or anomalies and all devices were certified sterile prior to release.Two-year complaint history review found this to be the only report of this nature for this part number.Further review for all part numbers in the 39-ph-xxxx-s reform ha coated pedicle screw, sterile family found this to be the only report of infection found.The investigation could not verify or identify any evidence of product error contribution to the reported problem.There are warnings in the package insert that state that this type of event can occur.Ifu lbl-ifu-021, reform ha coated pedicle screw system, lists under possible adverse effects: 10.Infection.As this is the only report of this nature for this lot and the product was certified sterile prior to release, the need for corrective action was not indicated.This report is number 1 of 4 mdrs filed for the same event (reference 3005739886-2015-00030 / 00033).
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Information provided, along with sales history, indicates that the patient underwent a single level fusion procedure on (b)(6) 2019, utilizing the reform ha coated sterile pedicle screws.Subsequently, the patient presented with infection and procedures were performed (b)(6) 2019, (b)(6) 2019 & (b)(6) 2019.No details regarding these procedures were available, but based on sales history information, it appears that during the procedure performed on (b)(6) 2019 to address infection, four (4) reform ha coated pedicle screws 7.5mm x 40mm (lot 15351ps) that were implanted during the initial procedure were removed and replaced due to loosening caused by infection.
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