Description of Event or Problem · 1
IN 2009, STRYKER BIOTECH RECEIVED A REPORT THAT A FEMALE PATIENT WHO RECEIVED OP-1 PUTTY IN 2008, AS PART OR A MULTILEVEL FUSION DEVELOPED A POSTOPERATIVE WOUND INFECTION. THE PATIENT HAS TO BE HOSPITALIZED AS A RESULT OF THE INFECTION, AND AN UNSPECIFIED 'SURGICAL EXPLORATION' WAS PERFORMED. THE PATIENT WAS REPORTED TO HAVE RECOVERED FROM THIS EVENT. THE PHYSICIAN REPORTED THAT HE FELT THE EVENT WAS SERIOUS, BUT NOT RELATED TO THE USE OF THE OP-1 PUTTY. THE PHYSICIAN REPORTED THAT THE PATIENT SUFFERED FROM SEVERE OSTEO POROSIS AND POST TRAUMATIC KYPHOSIS AND HAD UNDERGONE A PREVIOUS FUSION ON AN UNSPECIFIED DATE. ADDITIONAL INFORMATION WILL BE REQUESTED. ON 07/01/2009: THE INITIAL INFORMATION PROVIDED BY THE REPORTER DID NOT IDENTIFY THE CATALOG NUMBER OF THE DEVICE, BUT STATED THAT THE PATIENT RECEIVED OP-1 PUTTY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE REPORTER WERE MADE ON 05/08/2009, 05/21/2009 AND 06/08/2009, BUT NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. INVOICE DOCUMENTATION SUBMITTED BY THE HOSPITAL TO STRYKER BIOTECH INDICATED THAT A PATIENT WITH THE SAME INITIALS, GENDER, AND DATE OF PROCEDURE RECEIVED THE FOLLOWING PRODUCTS: 4 UNITS OF OP-1 IMPLANT, CATALOG NUMBER 10025. THE PATIENT DOES NOT APPEAR TO HAVE RECEIVED OP-1 PUTTY AS REPORTED BY THE PHYSICIAN IN HIS INITIAL REPORT. THEREFORE, THE PRODUCT HAS BEEN CHANGED FROM OP-1 PUTTY TO OP-1 IMPLANT. STRYKER WILL SUBMIT MDR 1224732-2009-00029, TO THE OP-1 IMPLANT HDE WITH AN ACCOMPANYING STATEMENT THAT MDR 1224732-2009-00029 SHOULD REFLECT THE USAGE OF OP-1 IMPLANT TO THE OP-1 PUTTY HDE. IN ADDITION, INVOICE DOCUMENTATION SUBMITTED BY THE HOSPITAL TO STRYKER BIOTECH INDICATES THAT THIS PATIENT RECEIVED 1 UNIT CALSTRUX, CATALOG NUMBER 40010. THIS MDR REPORT REFLECTS THE CALSTRUX DEVICE USAGE. SEE MDR 1224732-2009-00029, WHICH CAPTURES THE OP-1 IMPLANT DEVICE USAGE.