This report is for an unknown - veptr implants/unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number, the device history records review could not be completed as no product was received.Investigation summary: 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.(b)(4).
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This report is being filed after the review of the following journal article: roye, b.Et al.(2017), comparison of complications and unplanned or visits between magnetically controlled growing rods and vertical expandable prosthetic titanium rib, spine deformity, vol.5, issue 6, pages 451-452 (usa).The purpose of this study is to compare complication risk and unplanned or visits between primary mcgr and veptr implants at 2-year follow-up from a single academic institution.A total of 52 patients were treated with an unknown synthes vertical expandable prosthetic titanium rib (veptr).The following complications were reported as follows: 10 patients had wound complications.4 patients had medical complications.20 patients had anchor migration (hook displacement, screw pullout, rib erosion).7 patients had miscellaneous implant complications (screw breach, curve progression, etc.).This is for an unknown synthes vertical expandable prosthetic titanium rib (veptr).This report is 1 of 4 for (b)(4).
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