FDA Adverse Event Injury Summary report: N

TSRH RODS, PLATES, SCREWS

MDR report key: 119501 · Received September 3, 1997

Report

Report Number
MW1012078
Event Type
Injury
Date Received
September 3, 1997
Report Date
September 3, 1997
Manufacturer
SOFAMOR DANEK GROUP INC.
Product Code
KWP
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
OH, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

ON JANUARY 19, 1996 DR. SURGICALLY IMPLANTED THE RODS, PLATES AND SCREWS INTO RPTR'S LUMBAR SPINE AND ALSO DID SPINAL FUSION (SECOND SURGERY). FROM JANUARY 19, 1996 TO OCTOBER 11, 1996 RPTR WAS IN CONSTANT EXCRUCIATING "10" PAIN. ON OCTOBER 11, 1996, DR. SURGICALLY REMOVED THE DEVICE. DR. ALSO NOTED IN HIS "OPERATIVE REPORT" OF 10/11/96 "DIFFICULTY LOCATING SPINAL INSTRUMENTATION. SURROUNDING EACH OF THE INSTRUMENTS WAS A VERY LARGE BURSA, WHICH WERE VERY MATURE AND FILLED WITH STRAW-COLORED CLEAR FLUID, CONSISTENT WITH BURSA FLUID. INSTRUMENTATION WAS SITTING IN MIDDLE OF THESE LARGE BURSA, AND WITH THE BURSA SAC AROUND IT. THE BURSAL SAC WAS THICK, IN SOME PLACES 2 MM, CONSISTENT WITH USUAL BURSAL LINING. ALL THE FLUID ENCOUNTERED DURING DISSECTION DEEP TO REMOVE INSTRUMENTATION WAS BURSAL SAC FLUID, THE TISSUE SENT FOR BOTH CULTURES AND MICROSCOPIC EXAMINATION." AFTER THE REMOVAL RPTR CONTINUES TO HAVE BACK PAINS OF 7/8 AND LEFT LEG AND LEFT KNEE PAINS OF 9/10 DAILY AND WITH SHORT ACTIVITIES OF SITTING, STANDING, WALKING AND LEANING THE PAINS INCREASE TO BACK PAINS OF 8/9 AND LEFT LEG AND LEFT KNEE PAINS OF 10 ON A DOCTORS SCALE OF 1 TO 10. ON 6/19/97 RPTR ENTERED THE EMERGENCY ROOM WITH EXTREME DIFFICULTY IN BREATHING DR. INSTRUCTED PT TO DISCONTINUE USE OF THE FENTANYL PAIN PATCH THAT DR. HAD PRESCRIBED ON 6/18/97 TRYING TO ELIMINATE THE USE OF PRESCRIPTIONS VICODIN, ROBAXIN, ELAVIL AND ZANTAC.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 TSRH RODS, PLATES, SCREWS Implant SPINAL FIXATION DEVICE KWP SOFAMOR DANEK GROUP INC. UNK UNK

Patients

Seq Age Sex Outcome Treatment
1 49 YR Hospitalization| L| R| S