Conclusion: no conclusion can be drawn at this time.
Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.
The actual device involved in this event is unknown.
There are two possible devices involved in the event as follows: monocryl (poliglecaprone 25) suture, monocryl plus antibacterial sutures.
It was reported that a patient underwent spinal surgery on (b)(6) 2011 and suture was used.
During the surgery, screws between t5 and t7 were removed and the surgical incision was closed with suture.
The patient experienced inflammation, redness, and extreme incisional pain of the wound.
Immediately after the surgery, the upper right quadrant of the patient's back became hypersensitive, red and swollen.
Six days after the surgery, the half inch area surrounding the incision turned red and was described as being on fire by the patient's mother.
The mother of the patient stated that pieces of the suture protruding from the wound could be seen.
The patient was seen by the operating orthopedic surgeon and the plastic surgeon who closed the incision.
The patient was given a course of keflex even though incision infection was ruled out upon examination.
The redness and the sensation of being on fire persisted.
The patient had difficulty with activities of daily living because of the pain.
The plastic surgeon opined the wound presentation was caused by the suture and has told the patient's mother that the reaction would dissipate once the suture absorption was complete.