Zimmer biomet complaint (b)(4).The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00388, 0001032347-2020-00389, 0001032347-2020-00390.Concomitant medical products: tmj system left standard mandibular component 50mm / 9 hole, part# 24-6551, lot# 891840d.Tmj system left fossa component, small, part# 24-6563, lot# 886880b.2.4mm system high torque (ht) cross-drive screw 2.7 x 10mm, part# 91-2710, lot# ni.Tmj system cross drive fossa screw 2.0mm x 7mm, part# 99-6577, lot# ni.Occupation ¿ patient.
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(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00388-1, 0001032347-2020-00389-1, 0001032347-2020-00390-1.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Lot identification is necessary for review of device history records, lot identification was not provided for items 99-6577.A definitive root cause cannot be determined.Single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.The user is required to sterilize the screws prior to the procedure.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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