Radiographs were not provided for review.The device has not returned; therefore, no further investigation can be completed at this time.The patient reportedly was exercising immediately prior to the onset of pain.It is not clear if the patient had adhered to the post-operative care plan communicated by the surgeon.Labeling review: "risks associated with implants in the spine, including the pcm cervical disc device, are: early or late loosening of the components; disassembly; bending or breakage of any or all of the components; implant migration; malpositioning of the implant; loss of purchase; sizing issues with components; anatomical or technical difficulties." "the patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components.The patient must be made aware that implant components may bend, break or loosen even though restrictions in activity are followed.".
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On (b)(6) 2015, a (b)(6) year old male underwent anterior cervical discectomy with antroplasty.During a postoperative visit, the patient reported sudden onset of neck pain and headache.A revision surgery occurred on (b)(6) 2016 to remove the device.It was noted the caudal portion of the device had migrated anterior 7mm and the cranial portion was still in the original position.
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