BIOMET MICROFIXATION TMJ SYSTEM RIGHT FOSSA COMPONENT SMALL; JOINT, TEMPOROMANDIBULAR, IMPLANT
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Model Number N/A |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Pain (1994); Sleep Dysfunction (2517); Difficulty Chewing (2670)
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Event Type
Injury
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Manufacturer Narrative
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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, 0001032347-2019-00446, 0001032347-2019-00447, 0001032347-2019-00448, 0001032347-2019-00449, 0001032347-2019-00450, 0001032347-2019-00451, 0001032347-2019-00452, 0001032347-2019-00453, 0001032347-2019-00454.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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Event Description
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It was reported the patient underwent a medical intervention to treat pain associated with their temporomandibular implants.The patient has facial pain that causes difficulty eating and sleeping.The patient has received botox injections and is currently prescribed lyrica, amitriptyline, and tramadol to treat pain and sleeplessness associated with pain.No additional patient consequences have been reported.
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Manufacturer Narrative
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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 fossa components were reviewed, no non-conformances were found.There are no indications of manufacturing defects.For all non-custom tmj fossa implants in the previous one year (from the notification date) involving pain, there is a complaint rate of (b)(4), which is no greater than the occurrence listed in the afmea.For all non-custom tmj fossa implants in the previous one year (from the notification date) involving noises, there is a complaint rate of (b)(4), which is no greater than the occurrence listed in the afmea.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.The following fields were updated:date of this report, describe event or problem, device availability, date received by manufacturer, type of report, follow up type, device evaluated by manufacturer, method code, conclusions code, additional narratives/data.
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Event Description
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This follow-up report is being submitted to relay additional information.
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Search Alerts/Recalls
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