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Catalog Number 34348 |
Device Problems
Device Operates Differently Than Expected (2913); Improper Device Output (2953)
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Patient Problem
No Information (3190)
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Event Type
Injury
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Event Description
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A doctor alleged that the herculite ultra composite was radiolucent on x-rays for four (4) patients.This is the third of four (4) reports.
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Manufacturer Narrative
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Specific patient information with regard to gender, age, and weight was not provided.It was reported that the doctor completed the restoration and took an x-ray for insurance purposes.On the x-ray, the doctor discovered that a radiolucent composite restoration.The doctor drilled out and replaced the restoration for the patient.To date, the patient is doing fine.An evaluation is anticipated but has not yet begun.
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Manufacturer Narrative
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The product involved in the alleged incident was not returned; therefore, a physical evaluation was performed on a retained sample from the same lot, yielding results within specification.A dhr review indicated that there were no deviations from the manufacturing process.In addition, no similar complaints were received with regard to this lot.
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Search Alerts/Recalls
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