(b)(4).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 was implanted with a 300mm titanium cannulated lateral entry femoral recon nail, a 6.5mm recon screw, and four (4) titanium stardrive locking screws on an unknown date to repair a femur fracture.On an unknown date, the patient reported feeling some pain after a fall.Upon evaluation, it was discovered that the fixation was collapsed and had failed.It was clarified that upon examination, it was noted that the complained devices had migrated.On (b)(6) 2016, the patient was returned to the operating room for a revision surgery to remove the complained devices.All of the devices were removed and found to be intact.The procedure was completed successfully with no reports of delay or medical intervention.This is report 1 of 3 for (b)(4).
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