AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION REVIEW COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: N/A. MANUFACTURER?S REFERENCE NUMBER: (B)(4).
D
Patient 1
A HEALTH CARE PROVIDER HAS REPORTED THAT FIVE PATIENTS WHO UNDERWENT BREAST RECONSTRUCTION EXPERIENCED TISSUE EXPANDER DEFLATION OVER THE PAST THREE TO SIX MONTHS. THE PHYSICIAN STATED THAT EITHER THE BACK OR PORT OF THESE EXPANDERS BLEW OUT. NO ADDITIONAL DETAILS AS TO THE NATURE OF THESE DEFLATIONS WERE MADE AVAILABLE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THESE DEFLATIONS ARE BEING REPORTED INDIVIDUALLY IN SEPARATE REPORTS. IF ADDITIONAL DETAILS ARE MADE AVAILABLE, THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED.