Model Number 70-1153-PRC0057 |
Device Problem
Accessory Incompatible (1004)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Multiple follow-ups were conducted to obtain additional information; however, the dentist refused to provide more information.Once the evaluation is completed, a supplemental report will be submitted.
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Event Description
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It was reported that a hahn tapered implant prosthetic short driver failed to engage onto screw head.The short driver did not want to engage with the implants after 1 time of use.The driver was used on the patient; however, there was no injury or impact to the patient.
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Manufacturer Narrative
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The reported short driver and a handle were returned for evaluation.A visual and microscopic inspection were performed on the returned driver and handle.The critical parameters of the driver were measured and no defects, nor non-conformities were found.A fit-check was performed on the driver with the drivers mating part (cover screw) and there was no issue found.A review of the device history record (dhr) was conducted.There was no evidence discovered, to indicate that a product defect or nonconformity contributed to the issue.The part met all the criteria called for in the production router.The reported driver had no issue engaging with lab hahn cover screws without dropping.Based on the evaluation, the complaint could not be confirmed.This event will be tracked and trended.
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Search Alerts/Recalls
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