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.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.
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It was reported that on an unknown date, the patient underwent a fracture fixation for a lateral fracture utilizing a locking compression plate (lcp) clavicular hook plate 3.5.The patient reported being able to feel the implant, and so the patient underwent a hardware removal procedure.It was noted that union was achieved after sixteen (16) weeks.This report is for a lcp clavicular hook plate.This is report 1 of 1 for (b)(4).
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