Catalog Number 37501 |
Device Problems
Fitting Problem (2183); Positioning Problem (3009)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Code Available (3191)
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Event Type
No Answer Provided
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Manufacturer Narrative
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There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.
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Event Description
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It was reported that a surgiguide was used to place a dental implant.The implant transfer was too shallow and the guide did not fit.The clinician reported that additional steps during the surgery were needed to place the implant deeper.A second corrective surgery was not needed.
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Manufacturer Narrative
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The products have been returned and investigation shows that the product has been manufactured according to our standards.The fit on the model was good, the product has been finished correctly, the matching of the digital plaster model was good as well as the extractions performed on the stone model.
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Search Alerts/Recalls
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