Device was used for treatment and not for diagnosis.On june 19, 2019, medcad received a phone call from a distributor sales representative requesting an accushape peek patient-specific implant for a patient for whom medcad had previously supplied a peek patient-specific implant.On june 25, 2019, medcad requested additional information regarding the event, via email, including the patient's weight.Communication with the initial reporter via telephone on june 28, 2019, determined that the device was explanted on (b)(6) 2018.According to communication with the initial reporter, the device was explanted after the patient experienced dehiscence at the incision site.The complainant also stated that there was "evidence of pneumocephalus underneath the bone flap." the complainant was unable to obtain the patient's weight.Review of production records determined that no nonconformities were generated during the production of the implant.Investigation was unable to determine a clear cause for the reported event.On (b)(6) 2019, medcad provided a new accushape peek patient-specific implant for the patient.
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On june 19, 2019, medcad received a phone call from a distributor sales representative requesting an accushape peek patient-specific implant for a patient for whom medcad had previously provided a peek patient-specific implant.Upon follow-up, it was reported by the distributor sales representative that the device had been explanted, after the patient experienced dehiscence at the incision site.
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