The investigation determined that the patient scan submitted by the doctor was taken on (b)(6) 2018.The related surgical guide case was requested on (b)(6) 2019 and fabrication completed on (b)(6) 2019.The surgery date was (b)(6) 2019.Therefore, the patient scan used to manufacture the guide was 10 months old by the time it was used for surgery.Per the technical data sheet that ships with each surgical guide, "anatomage guide is valid and functional for the duration of time that the intraoral morphology of the teeth and gingiva and their intraoral positions are identical to the morphology and positions of the teeth and gingiva as captured in the ct scan of the stone model from which the anatomage guide was produced." to account for shifts in patient morphology over time, anatomage procedure instructs technicians to check that the scan date is less than or equal to 6 months old.Therefore, the age of the patient scan should have been communicated to the doctor and a new scan should have been requested.As this expectation was not followed, it is possible that the manufactured guide deviated from the patient's current morphology as it was based on a 10 month old scan.The doctor's treatment plan was also reviewed.It shows that implant #2 is planned into the patient's sinus cavity, which if left unaddressed, would cause complications during surgery and may necessitate a graft.However, the doctor did not provide additional details on why a graft was needed.The device was not returned after several requests to send it to anatomage for evaluation.Therefore, the most likely causes of this issue was the doctor's treatment plan and the use of an outdated patient scan to manufacture the guide.[(b)(4)].
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