FDA Adverse Event Injury Summary report: N

MAST QUADRANT RETRACTOR SYSTEM

MDR report key: 5006639 · Received August 11, 2015

Report

Report Number
MW5055393
Event Type
Injury
Date Received
August 11, 2015
Date of Event
June 30, 2015
Report Date
August 11, 2015
Manufacturer
MEDTRONIC
Product Code
FSZ
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MA, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

PT IS A (B)(6) MALE WITH THE LOW BACK PAIN AND BILATERAL EXTREMITY PAIN AND NUMBNESS. PT HAD BEEN EXPERIENCING PROGRESSIVELY WORSENING SYMPTOMS DESPITE NON-OPERATIVE MANAGEMENT. PT CONSENTED TO SURGICAL TREATMENT. PT STATUS POST LEFT L3-4 DIRECT LATERAL INTERBODY FUSION WITH POSTERIOR INSTRUMENTATION ON (B)(6) 2015; AFTER SURGERY, WHEN DRAPES WERE REMOVED, THE PT WAS FOUND TO HAVE A LEFT FLANK "BURN" OF 7 X 2.5 CM NON-BLANCHABLE ERYTHEMA WITH A FLUID FILLED BLISTER IN THE CENTER MEASURING 3.5CM X 1.5 CM. THERE WAS NO EVIDENCE OF ANY 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 BY THE CLINICAL ENGINEERING DEPARTMENT. THE BURN AREA WAS COVERED WITH A STERILE DRESSING AND A WOUND CARE SPECIALIST WAS CONSULTED. POSTOPERATIVELY THE LEFT FLANK WOUND WAS CLEAN AND HEALING APPROPRIATELY. PT WAS FOLLOWED CLOSELY BY THE WOUND CONSULT SERVICE. THE SPINE SERVICE CHECKED WOUND AT DISCHARGE AND PT WAS TO F/U IN TWO WEEKS. PT'S SPINE SURGEON SPOKE TO DERMATOLOGIST AND ORDERED SILVER SULFADIAZINE 1% CREAM APPLICATION WITH TAPE TWICE DAILY AND INSTRUCTED TO COVER WITH DRESSING. PT DISCHARGED HOME WITH HOME (B)(6) SERVICES FOR DRESSING CHANGES AND WOUND MONITORING. UPON F/U VISIT WITH THE SPINE SURGEON ON (B)(6) 2015, 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. REASON FOR USE: VISUALIZATION OF DEEP INCISION WITH LIGHTED RETRACTOR.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
525017 MAST QUADRANT RETRACTOR SYSTEM MAST QUADRANT RETRACTOR SYSTEM FSZ MEDTRONIC 00 MLX 0362288W
525018 MLX LIGHT SOURCE MLX LIGHT SOURCE FCW INTEGRA LUXTEC
525019 MAST QUADRANT RETRACTOR / ILLUMINATION SYSTEM MAST QUADRANT RETRACTOR / ILLUMINATION SYSTEM FSZ MEDTRONIC SOFAMOR DANEK 0362288W
525020 STRYKER FO CABLE 5M STRYKER FO CABLE 5M GEI STRYKER 233-050-064 102775
525021 MEDTRONIC LATERAL RETRACTOR ASSY. MEDTRONIC LATERAL RETRACTOR ASSY. GAD MEDTRONIC DC07A008
525022 MEDTRONIC LATERAL RETRACTOR ASSY. MEDTRONIC LATERAL RETRACTOR ASSY. GAD MEDTRONIC FA09C044
525023 MEDTRONIC LATERAL RETRACTOR ASSY. MEDTRONIC LATERAL RETRACTOR ASSY. GAD MEDTRONIC FA13E015
525024 STRYKER LIGHT CABLE STRYKER LIGHT CABLE FST STRYKER
525025 MEDTRONIC DISPOSABLE FO CABLE DISPOSABLE FO CABLE GEI MEDTRONIC SOFAMOR DANEK

Patients

Seq Age Sex Outcome Treatment
1 51 YR Other