Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.It is unknown at this time if the device will be returned for evaluation.The product remains implanted in the patient, but a revision may occur at a later unspecified date at which time the device may be returned for testing.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00566, 0001032347-2019-00567, 0001032347-2019-00569, 0001032347-2019-00570, 0001032347-2019-00571, 0001032347-2019-00572.Medical products: tmj system right standard mandibular component, part# 24-6545, lot# 535280d, 2.4mm system high torque (ht) cross-drive screw, part# 91-2708, lot# unk, 2.4mm system high torque (ht) cross-drive screw, part# 91-2710, lot# unk, 2.4mm system high torque (ht) cross-drive screw, part# 91-2712, lot# unk, traumaone system 2.0x9mm self-drilling imf screw, part# 91-5609, lot# unk, omnimax 24 gauge prestretch, part# 99-5824, lot# unk, 2.7mm system emergency cross drive screw, part# 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.Three additional follow up attempts were made; however, no additional information was received.The patient did not state what led to the need for a revision surgery.The screws used in this case were not reviewed in the database due to their lot numbers being unknown.There are no indications of manufacturing defects.The most likely underlying cause cannot be determined.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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