MAST QUADRANT RETRACTOR SYSTEM

Additional Manufacturer Narrative

(B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

AS PER VOLUNTARY MEDWATCH FORM, PATIENT HAD LOW BACK PAIN AND BILATERAL EXTREMITY PAIN AND NUMBNESS. PATIENT HAD BEEN EXPERIENCING PROGRESSIVELY WORSENING SYMPTOMS DESPITE NON-OPERATIVE MANAGEMENT. PATIENT CONSENTED TO SURGICAL TREATMENT. PATIENT STATUS POST LEFT L3-4 DIRECT LATERAL INTERBODY FUSION WITH POSTERIOR INSTRUMENTATION IN 2015. WHEN DRAPES WERE REMOVED, THE PATINET WAS FOUND TO HAVE A LEFT FLANK "BURN" OF 7X2.5 CM OF NON-BLANCHABLE ERYTHEMA WITH A FLUID FILLED BLISTER IN THE CENTER MEASURING 3.5 CM X 1.5 CM. THERE WAS NO EVIDENCE TO THE ALTERATION TO THE STERILE DRAPES (I.E. BURN MARK). THIS DISCOVERED EVENT WAS DISCUSSED/EXAMINED BY THE SURGICAL TEAM, ANESTHETIC TEAM AND THE CIRCULATING NURSE. THE SURGICAL TEAM DISCUSSED THE POSSIBILITY OF THE BURN OCCURRING FROM THE LIGHT CORD CONNECTION TO THE FIBEROPTIC CABLE AND ALL COMPONENTS WERE COLLECTED/DELIVERED TO THE OPERATING ROOM MANAGER FOR FULL INVESTIGATION. THE BURN AREA WAS COVERED WITH A STERILE DRESSING AND A WOUND CARE SPECIALIST WAS CONSULTED. POST-OP THE LEFT FLANK WOUND WAS CLEAN AND HEALING APTLY. PATIENT WAS FOLLOWED CLOSELY BY THE WOUND CONSULT SERVICE. THE SPINE SERVICE CHECKED WOUND AT DISCHARGE AND PATIENT WAS TO FOLLOW UP IN 2 WEEKS. PATIENT'S SPINE SURGEON SPOKE TO DERMATOLOGIST AND ORDERED SILVER SULFADIAZINE 1% CREAM APPLICATION WITH TAPE TWICE DAILY AND INSTRUCTED TO COVER WITH DRESSING. PATIENT DISCHARGED HOME WITH HOME SERVICES FOR DRESSING CHANGES AND WOUND MONITORING. UPON FOLLOW UP VISIT WITH THE SPINE SURGEON IT WAS DISCOVERED THAT THE BURN HAD INCREASED TO A SERIOUS REPORTABLE EVENT REQUIRING A CHANGE IN THE TREATMENT PLAN WITH QUESTION DEBRIDEMENT OF WOUND AND INCREASED DRESSING CHANGES.

Additional Manufacturer Narrative

(B)(4)

Description of Event or Problem

THE PRODUCT CAME IN CONTACT WITH THE PATIENT.

Description of Event or Problem

IT WAS REPORTED THAT, INTRA-OP, A BURN WAS NOTICED AFTER THE FIELD WAS BROKEN DOWN. SOME PORTION OF THE RETRACTOR LIGHTING SYSTEM CAUSED THE ISSUE. THE PRODUCT CONTACT WITH THE PATIENT IS UNKNOWN. THE PATIENT IS ALIVE WITH INJURY(BURN).