Expiration date and lot number 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.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventive 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 (b)(6) 2017, a hardware removal of rapid resorbable strut plate was performed due to infection.There was an unknown allegation against the battery pack-sterile for battery powered driver.On an unknown date, the patient presented with fever and infection at the surgical site.The parents admitted allowing their dog to lick the wound site on babies head that probably caused the infection.Initially, the patient had a sagittal synostosis procedure on (b)(6) 2017.It is unknown if there was a surgical delay.Procedure outcome and patient status were unknown.This complaint involves one (1) device.This report is 3 of 5 for (b)(4).
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