Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Failure of Implant (1924)
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Event Date 12/07/2021 |
Event Type
Injury
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Manufacturer Narrative
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Based on our investigation, we can conclude that the guide was fabricated for the incorrect drill length due to an internal error.However, the returned guide passed its trajectory analysis, and the longer drill length should not have contributed to the trajectory deviation.As such, the cause of the deviation could not be determined, and may have been due to complex clinical aspects outside the scope of this investigation.
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Event Description
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The guide was used for implant surgery.The doctor stated that the guide sat well on the dental model and patient.However, it was fabricated for a 21 mm drill instead of for a 15mm drill as he had requested.Additionally, after using the pilot drill, he noticed that the osteotomy was closer to tooth #4 than intended.He decided to trust the guide and proceeded with surgery, but the implant ended up being ~1-1.5mm from the root of tooth #4 which was closer than planned.The implant was removed at a later date, and the doctor grafted the site.
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Manufacturer Narrative
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Based on our investigation, we can conclude that the guide was fabricated for the incorrect drill length due to an internal error.However, the returned guide passed its trajectory analysis, and the longer drill length should not have contributed to the trajectory deviation.As such, the cause of the deviation could not be determined, and may have been due to complex clinical aspects outside the scope of this investigation.
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Event Description
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The guide was used for implant surgery.The doctor stated that the guide sat well on the dental model and patient.However, it was fabricated for a 21 mm drill instead of for a 15mm drill as he had requested.Additionally, after using the pilot drill, he noticed that the osteotomy was closer to tooth #4 than intended.He decided to trust the guide and proceeded with surgery, but the implant ended up being ~1-1.5mm from the root of tooth #4 which was closer than planned.The implant was removed at a later date, and the doctor grafted the site.
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Search Alerts/Recalls
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