Information was received from health care professional via manufacturing representative regarding patient with stenosis spondylolisthesis for spinal therapy.Patient demographics: gender: male; age: (b)(6).Outcome: alive no injury.Event was intra-op.Procedure used was mast tlif.Levels implanted: l4-s1 it was reported that the light source is inserted into the metrx tube per its ifu.However, after about an hour, the light source comes apart at the end.The two pieces of metal basically split in two, with one piece falling off, exposing the light.Of course the light is hot so this poses a burn risk to the patient as well as the surgical staff.It also poses a fire hazard to the patient and the or.Lastly, there is the potential for the one piece of metal that falls off to become lodged into the patient or fall into the would be unknown to the surgeon and staff.Fortunately in this case, none of these more serious issues occurred.The lights and the piece of disassociated metal were removed from the patient and discarded.No patient symptoms were reported.No further complications reported.
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