Through internal review of historical cases, medcad discovered that approximately 6 months after providing an accushape patient-specific cranial implant (psci) for the patient, a second implant was provided for the same patient with the same defect, indicating that the previous accushape psci was explanted.
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According to the surgeon, the device was explanted approximately 6 months after it was implanted.The device in question was used for treatment and not for diagnosis.The device was implanted in (b)(6) 2017, though the exact date of implant is unknown.Review of the device history record found that the patient-specific device was manufactured, at the request of the surgeon, with a modified surface pattern.Communication with the surgeon on december 31, 2019, revealed that the device was explanted after the patient developed an infection.According to the surgeon, the infection was caused by the patient "picking" at the incision site.Per communication with the surgeon, it was determined that the device was explanted in (b)(6) 2017, however, the exact date of explant is unknown.The device was not returned for evaluation and the cause of the patient infection could not be verified.Medcad contacted the distributor sales representative via email on december 9, 2019, to request additional information from the surgeon, including the patient's weight at the time of the event.An additional follow-up phone call to obtain the patient's weight was made with distributor sales representative on january 8, 2020.After multiple attempts, medcad was unable to obtain the patient's weight at the time of the event.
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