This report is for one (1) unknown veptr implant.Part#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.This report is for one (1) unknown veptr implant.Pma/510(k) number is not available.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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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It was reported that on (b)(6) 2018, the patient underwent a bilateral expandable surgery, for broken vertical expandable prosthetic titanium rib (veptr) implants due to the patient playing dodgeball at school and he felt a pop.The break was on the left device, horizontal across one of the notch openings.Procedure was completed successfully with no delay.Patient outcome is unknown.Patient had multiple revision surgeries to adjust the device as the patient's spine grows and/or scoli curve changes.This report is for one (1) unknown veptr implant.This is report 1 of 1 for (b)(4).
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