Zimmer biomet complaint (b)(4).Medical product: zimmer biomet tmj system right narrow mandibular component, 45 mm catalog #: 01-6545, lot #: 859610a; zimmer biomet tmj system left narrow mandibular component, 45 mm catalog#: 01-6546, lot#: 787750c; zimmer biomet tmj system right fossa component, small catalog#: 24-6562, lot#: 857280b; zimmer biomet "2.4 mm" system high torque (ht) cross-drive screw catalog#: 91-2708, lot#: ni; zimmer biomet tmj system left fossa component, small catalog#: 24-6563, lot#: 882250c; zimmer biomet tmj system cross drive emergency fossa screw catalog#: 99-6587, lot#: ni; zimmer biomet tmj system cross drive fossa screw catalog#: 99-6577, lot#: ni; zimmer biomet "2.4 mm" system high torque (ht) cross-drive screw catalog#: 91-2710, lot#: ni.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00318, 0001032347-2019-00319, 0001032347-2019-00320, 0001032347-2019-00321, 0001032347-2019-00322, 0001032347-2019-00323, 0001032347-2019-00324, and 0001032347-2019-00325.
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This follow-up report is being submitted to relay additional information.As a revision occurred, the complaint is confirmed.Functional testing and inspections could not be performed due to the parts not being returned and no photographs, x-rays, ct scans, or physician reports being provided.The dhrs for the screws could not be reviewed due to the lot numbers being unknown.There are no indications of manufacturing defects.For all 2.0x7mm fossa x-dr scrw (part# 99-6577) in the previous year (from the notification date), there is a complaint rate of 0.34%, which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the complaint cannot be determined.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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