Patient Problem
No Known Impact Or Consequence To Patient (2692)
Event Date 06/28/2016
Event Type
malfunction
Manufacturer Narrative
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.
Event Description
It was reported that the patient underwent posterior lumbar interbody fusion surgery at l2-l3 levels, for the treatment of spinal canal stenosis.Intra-op, at the time of inserting a set screw to a t-bolt connector, cross-threading occurred.Burr was generated during inserting the set screw into the connector.The set screw and the connector were replaced.The product came in contact with the patient.No patient complications were reported.
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.