FDA Adverse Event Malfunction Summary report: N

JARIT

MDR report key: 3239473 · Received July 16, 2013

Report

Report Number
MW5030953
Event Type
Malfunction
Date Received
July 16, 2013
Date of Event
July 8, 2013
Report Date
July 16, 2013
Manufacturer
INTEGRA LIFE SCIENCE
Product Code
HTX
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
KS, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

PROCEDURES: LYSIS OF EPIDURAL ADHESIONS FROM PRIOR DECOMPRESSIVE L4-L5 LUMBAR LAMINECTOMY. COMPLETE BILATERAL FORAMINOTOMY L4-L5 AND REMOVAL OF RESIDUAL LAMINA FROM L4-L5. PEDICLE SCREW AND ROD STABILIZATION BILATERALLY WITH TRIOS STRYKER PEDICLE SCREWS L4-L5. INTERBODY FUSION WITH AUTOLOGOUS BONE GRAFT INFUSED BMP AND CORTICAL STRYKER UNILIFT SPACER. EPIDURAL FAT GRAFT. DURING PROCEDURE, THE SURGEON USED A NARROW PITUITARY RONGEUR TO ENTER THE DISK SPACE. THE SECOND TIME, THE PITUITARY RONGEUR WAS OPENED, THE UPPER JAW BROKE OFF INTO THE INTERSPACE. ADDITIONAL VARIOUS OTHER INSTRUMENTS, CURETS, OTHER PITUITARIES. REAMERS, AND AWL WERE USED TO CLEAN THE DISK MATERIAL AND SEPARATE THE COLLAPSED VERTEBRAE. THE C-ARM FLUOROSCOPE WAS BROUGHT BACK DUE TO NOT BEING ABLE TO SEE OR FEEL THE REMAINING PORTION OF THE PITUITARY RONGEUR. IT WAS SEEN IN THE SUPERIOR ENDPLATE. CURETS WERE USED TO TRY AND REMOVE IT. IT WAS FELT THAT IT WAS COMPLETELY IMBEDDED IN THE CARTILAGINOUS PLATE, AND UNABLE TO DISLODGE IT. IT WAS FELT TO BE SAFER JUST TO LEAVE IT IN THIS POSITION, AS IT WAS SOLIDLY IMBEDDED. IT WAS NOT GOING TO GO ANYWHERE. ENLARGING THE DISK SPACE TO GET ENOUGH ROOM TO GET IT OUT WOULD JUST SIMPLY LEAD TO SOME MORE INSTABILITY AND PERHAPS MORE PROBLEMS. THE INTERSPACE SPACE WAS THEN PACKED WITH THE INFUSED BMP SPONGE. NOTE: INSTRUMENT WAS LAST SERVICED (B)(6) 2013 BY (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
328769 JARIT PITUITARY RONGEUR HTX INTEGRA LIFE SCIENCE 280-405

Patients

Seq Age Sex Outcome Treatment
1 70 YR