ALLOCRAFT DBM, 10CC - 3 PACKAGES -
Received Dec 4, 2009 · Event occurred May 11, 2009
Report MW5013828 · MDR key 1556544
Device
Product problems
- Insufficient Device Problem Information
Patient
62 YR
- Abscess
- Bacterial Infection
- Erythema
- Fever
- Hematoma
- Malaise
- Fluid Discharge
Narrative
Description of Event or Problem
IN 2009, PT UNDERWENT SURGICAL PROCEDURE FOR REVISION POSTERIOR SPINAL FUSION WITH INSTRUMENTATION, L3-L4 HARDWARE REPLACEMENT AND L1-L2 SMITH-PETERSEN OSTEOTOMY. THE FOLLOWING MONTH, PT ADMITTED WITH REDNESS AT INCISION, COMPLAINT OF FEELING ILL AND NO DRAINAGE AND FEVERS OVER PREVIOUS 2 DAYS - 102.4C -. PT STARTED ON VANCOMYCIN. THE WOUND WAS FOUND TO HAVE SPONTANEOUS DRAINAGE AND HEMATOMA DEEP TO FASCIA AND GROSSLY PURULENT FIVE DAYS LATER. IRRIGATION AND DEBRIDEMENT PROCEDURE PERFORMED. PT STARTED ON CEFEPIME, FLAGYL, VANCOMYCIN AND VANCOMYCIN IMPREGNATED BEADS PLACED. PT DISCHARGED FOUR DAYS LATER AND READMITTED SEVENTEEN DAYS LATER. WOUND SITE SHOWING ERYTHEMA, SANGUINOUS DRAINAGE AND BLISTERS ON PREVIOUS WOUND SITE. PT EXPERIENCED LOW GRADE FEVERS OVER PREVIOUS WEEK. VANCOMYCIN AND RIFAMPIN STARTED AT ADMISSION. THE FOLLOWING DAY, PT UNDERWENT AN IRRIGATION AND DEBRIDEMENT PROCEDURE. THE PROCEDURE SHOWED NO SUPERFICIAL INFECTION AND THE HEMATOMA WAS EVACUATED. VANCOMYCIN IMPREGNATED BEADS PLACED AND CONTINUED ON IV VANCOMYCIN, AND RIFAMPIN. FOLLOW-UP APPOINTMENT IN JULY, SHOWED THAT WOUND HAD HEALED, THE PT NO LONGER TAKING VANCOMYCIN, BUT STARTED ON DOXYCYCLINE. DOSE OR AMOUNT: 30 CC TOTAL. DATES OF USE: 2009 TO PRESENT. DIAGNOSIS OR REASON FOR USE: POSTERIOR SPINAL FUSION.