BIOMET MICROFIXATION TMJ SYSTEM 55 MM LEFT STANDARD MANDIBULAR COMPONENT; JOINT, TEMPOROMANDIBULAR, IMPLANT
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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Difficulty Chewing (4522)
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Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).D10 ¿ medical products: item # 24-6556, lot # 724260a; tmj system 55 mm left standard mandibular component, item # 24-6563, lot # 863550c; tmj system left fossa component, small.G2: consumer: patient, g2: other: family member, the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2023-00286.
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Event Description
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It was reported that the patient underwent a temporomandibular joint procedure.Subsequently, the patient is experiencing pain.Chewing causes a lot of pain.No revision procedure has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.
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Event Description
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No further event information is available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported event is unconfirmed.If any further information is found that would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.This report is being submitted to update additional information in sections b4, b5, d4, g3, g6, h2, h3, h4, h6, and h10.
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