Catalog Number CHG020 |
Device Problem
Fracture (1260)
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Patient Problems
Failure of Implant (1924); Pain (1994); Ankylosis (4527)
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Event Date 04/02/2024 |
Event Type
Injury
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Event Description
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It was reported that it was discovered post operative, the right fossa component is broken.The surgeon will perform a revision surgery to remove the tmj devices.
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Manufacturer Narrative
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Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.
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Manufacturer Narrative
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The event has been confirmed as the surgeon provided imaging showing the right fossa component was fractured.The surgeon plans to remove and revise the right fossa component.Based on the investigation, there is no indication of a malfunctioning product or any issues related to design, material, or manufacturing.
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Event Description
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It was reported that it was discovered post operative, the right fossa component is broken.The surgeon will perform a revision surgery to remove the tmj devices.
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Search Alerts/Recalls
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