Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.The device will not be returned for evaluation as it remains implanted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00444, 0001032347-2019-00445, 0001032347-2019-00446, 0001032347-2019-00447, 0001032347-2019-00448, 0001032347-2019-00449, 0001032347-2019-00450, 0001032347-2019-00451, 0001032347-2019-00452, 0001032347-2019-00453.Concomitant medical products: tmj system left fossa component small, cat# 24-6563, lot# 761290a; tmj system right fossa component small, cat# 24-6562, lot# 783330b; tmj system left standard mandibular component, cat# 24-6551, lot# 751050c; tmj system right standard mandibular component, cat# 24-6550, lot# 759080a; "2.4mm" system high torque (ht) cross-drive screw, cat# 91-2708, lot# unk; "2.44mm" system high torque (ht) cross-drive screw, cat# 91-2710, lot# unk; traumaone system 2.0x7mm self-drilling imf screw, cat# 91-5607, lot# unk; traumaone system 2.0x9mm self-drilling imf screw, cat# 91-5609, lot# unk; tmj system cross drive fossa screw, cat# 99-6577, lot# unk; tmj system cross drive emergency fossa screw, cat# 99-6587, lot# unk; "2.7mm" system emergency cross drive screw 1/pkg, cat# 99-9948, lot# unk.Occupation: patient.
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This follow-up report is being submitted to relay additional information.The complaint is non-verifiable.No product was returned; therefore, no functional tests or inspections could be performed.No x-rays, scans, pictures, or physician's reports were provided.The dhrs for the screws involved in this case could not be reviewed due to the lot numbers being unknown.There are no indications of manufacturing defects.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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