Description of Event or Problem · 1
THIS REPORT IS SUBMITTED IN REGARD TO THE STRYKER RECALL FOR CRANIOPLASTY KITS. PATIENT IS A FEMALE WHO HAD AN EVACUATION OF A SUBDURAL HEMATOMA AND CRANIECTOMY IN 2007. APPROX SEVEN AND A HALF MONTHS LATER, SHE UNDERWENT A CRANIOPLASTY USING AN ALLOGRAFT WHICH WAS SUBSEQUENTLY RESECTED THE FOLLOWING MONTH, SECONDARY TO AN INFECTION CAUSED BY AN OPENING OF THE SCALP OVER THE CRANIAL BONE FLAP AND A PROGRESSIVE SCALP DEFECT EXPOSING THE BONE FLAP TO THE OUTSIDE WORLD. THE BONE FLAP WAS REMOVED AND THE PATIENT UNDERWENT AN EXTENDED COURSE OF IV ANTIBIOTICS. IN 2008, AS SCHEDULED, THE PATIENT UNDERWENT ANOTHER CRANIOPLASTY, THIS TIME USING THE STRYKER CUSTOM CRANIAL IMPLANT KIT -WHICH LATER BECAME THE SUBJECT OF A STRYKER RECALL APPROX SEVEN MONTHS LATER-. FIVE DAYS PRIOR, THE PT UNDERWENT A SECOND CRANIOPLASTY SECONDARY TO A SUBSTANTIALLY SIMILAR OPENING OF THE SCALP OVER THE CRANIAL BONE FLAP AND A PROGRESSIVE SCALP DEFECT EXPOSING THE BONE FLAP TO THE OUTSIDE WORLD. THE PLAN ON THAT DATE WAS TO REMOVE THE BONE FLAP AND TO REPAIR THE LARGE SCALP DEFECT WITH A ROTATION SCALP FLAP. THE FLAP WAS CULTURED FOR INFECTION AND CAME UP NEGATIVE. THE PATIENT HAS REMAINED INFECTION-FREE AS OF THIS DATE. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: CRANIOPLASTY.