This report is against user facility medwatch number mw5090961, a copy is attached.The only information contained in this report is correction or additional information.This report is for an unknown spine screw/unknown lot.Part and lot numbers 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.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.(b)(4).
|
Initial report of event was reported from patient under fda complaint form mw5090961: it was reported that on (b)(6) 2014, the patient broke their back from a fall and was implanted with a titanium rod, six (6) screws, and two (2) squirrel cages.The patient experienced pain, rash, hives, and itching at surgery site immediately post-operatively.The symptoms continued to worsen and the patient started having anaphylaxis episodes requiring allergic reaction treatment.Allergy tests completed "comfirmed" the patient was highly 3++ allergic to titanium, nickel, cobalt, and magnesium.Hardware revision surgery occurred on may 24, 2019 and the rod was removed.The patient continues to have allergic reactions post revision surgery.This is report 2 of 10 for (b)(4).This report is for an unknown screw.
|