Device was used for treatment and not for diagnosis.On (b)(6) 2018, a sales representative informed medcad that during surgery, it was determined that the accushape peek patient-specific cranial implant did not fit the patient as intended.Review of production records for this case determined that, upon request of the surgeon, the patient-specific implant was designed and manufactured using ct data that was greater than 3 months old.Surgery was completed without implanting the device, and a second accushape peek patient-specific cranial implant was requested.A second ct scan, dated (b)(6) 2018, was sent with the request for a new implant.The new accushape implant was manufactured and distributed on august 6, 2018.During a telephone conversation on (b)(6) 2018, the complainant reported that the patient was in fair condition.The complainant was unable to confirm what had been done with the original implant.The complainant was unable to confirm the patient's weight.If additional information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
|
On (b)(6) 2018, a sales representative notified medcad that the accushape peek patient-specific cranial implant did not fit the patient as intended.During the surgery, it was determined that the implant would not adequately fit the patient's defect.Surgery was completed without implanting the device, and a second accushape patient-specific implant was requested.
|