(b)(4).Implant date: (b)(6) 2017.Concomitant medical device: biomet microfixation "2.4 mm" system high torque (ht) cross-drive screw, 2.7 x 8 mm, catalog #: 91-2708, lot #: ni; biomet microfixation "2.4 mm" system high torque (ht) cross-drive screw, 2.7 x 10 mm, catalog #: 91-2710, lot, #, ni; biomet microfixation tmj system cross-drive fossa screw, 2.0 x 7 mm, catalog #: 99-6577, lot #: ni; biomet microfixation custom made device parent pm-tmj & model, catalog #: tmjpm-1856, lot #: 782060a; biomet microfixation tmj system cross drive fossa screw, 2.0 x 11 mm, catalog #: 99-6581, lot #: ni; biomet microfixation tmj system cross drive emergency fossa screw, 2.3 x 9 mm, catalog #: 99-6589, lot #: ni.Therapy date: unknown.Foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, the implant is currently implanted in the patient.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: 0001032347-2018-00574, 0001032347-2018-00575, 0001032347-2018-00576, 0001032347-2018-00577, 0001032347-2018-00579, 0001032347-2018-00580.
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This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of patient scans.The design vendor conducted an investigation into the complaint; their investigation is as follows: on the web meeting held (b)(6) 2018, the surgeon and tmj designer reviewed the previous left tmj implant placement from tmjpm-1856 in 2017, the joint was not implanted in the planned position.It was agreed upon with the surgeon that the best course of action was to remove the left side tmj implants (fossa and mandibular components) and design new implants to replace them.Device history record (dhr) review was unable to be performed for the screws as the lot number of the devices involved in the event are unknown.Dhr was reviewed for the tmj and no discrepancies were found.There are no indications of manufacturing defects.Investigation results concluded that the reported event was due to the implants not being implanted in the planned position during initial implantation.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00574-1, 0001032347-2018-00575-1, 0001032347-2018-00576-1, 0001032347-2018-00577-1, 0001032347-2018-00579-1, 0001032347-2018-00580-1.
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