(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.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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Patient for revision surgery after spondylodesis c4/5 with autologues bone graft and skyline plate on (b)(6) 2018.Current revision surgery because of persisting pain in neck and arms.Unclear if low grade infect, non union in radiology.During implant removal, it was found, that one of the skyline screws in c5 was broken.The tip of the screw was left in the vertebral body because it was impossible to remove.Surgery went on as planned and a longer plate was implanted.Removed implants were send for sonification and will not be available for examination.Was surgery delayed due to the reported event? --> no, action taken when event occurred? --> none, screw tip was left in place, was procedure successfully completed? --> yes, were fragments generated? --> unknown, if yes, were they removed easily without additional intervention? --> no, patient status/ outcome / consequences --> unknown, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> unknown, other information --> patient has a strong nickel allergy and was intensively tested for other kinds of allergy like tan, tav, ticp before primary surgery.None of them could be confirmed., is the patient part of a clinical study --> no.Concomitant device reported: unknown plate (part# unknown, lot# unknown, quantity unknown).This complaint involves one (1) device.
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