Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|
It was reported that patient presented with pre-op diagnosis as cervical spondylotic myelopathy.For which, patient underwent hemi-partial laminoplasty.Intra-op, after "od" of c4/6, two screws at c5 (lamina side) were found to be backed out completely and they were moved toward spinous process at c7.The screw size was probably 2.6×7 mm ( both of them), but the details are unknown.Used plate was unknown.No schedule for re-operation.The products came in contact with the patient.No patient complications were reported.
|