This report is being filed after the subsequent review of the following literature article; (october 2012) ¿stand-alone anchored spacer versus anterior plate for multilevel anterior cervical diskectomy and fusion.¿ yang; orthopedics healio.Com/orthopedics; october 2012|volume 35 - november 10.This article reports on a study total of 51 consecutive patients with cervical spondylotic myelopathy that compared surgical parameters, clinical and radiological outcomes, and complications in patients who underwent three or four level anterior cervical discectomy and fusion with stand along anchored implants that were divided into 2 groups.(zero p implant) group a or with an anterior plate system (syncage)group b.Technique related complications reported on implant group b (syncage) are: one case of cerebrospinal fluid leakage occurred due to a dual tear intro operatively due to tight adhesion.Patient recovered after three to five days of local pressure.Also reported were hoarseness, epidural hematoma, cage subsidence and c5 palsy.One patient on group b developed epidural hematoma recovered neurological function after emergency evacuations and pulse methylprednisolone therapy.No long term neurological deficit was observed.This report is for 2 of 2 implants for com-(b)(4).Unknown syncage implant, unknown quantity/unknown part number and unknown lot number.(group b) a copy of the literature article is being submitted with this medwatch.
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Device was used for treatment, not diagnosis.(b)(6).Stand-alone anchored spacer versus anterior plate for multilevel anterior cervical diskectomy and fusion.Orthopedics (b)(6); october 2012|volume 35 - november 10.This report is for unknown syncage implant, unknown quantity, unknown item number, (b)(4) the investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot and part number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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