Exact age/date of birth is unknown; reported as being (b)(6).The 510k: this report is for an unknown veptr rib hook/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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a patient who had been implanted with a unilateral vertical expandable prosthetic titanium rib (veptr ii) system on an unknown date, underwent a simple veptr distraction on (b)(6) 2017.However, it was known preoperatively that the rib hook had pulled loose.The surgeon replaced the rib hook, extended it another level from t4 to t3 with a rib hook extension and replaced the proximal extension.It was reported that the final x-ray confirmed good fixation.The surgery was completed successfully and the patient was reported as stable.Concomitant devices: veptr rib hook extension (quantity 1), veptr proximal extension (quantity 1).This report is for an unknown veptr rib hook.This is report 1 of 1 for (b)(4).
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