BRÅNEMARKSYST MKIII GROOVY RP3.75X11.5MM

Additional Manufacturer Narrative

INTERNAL REFERENCE NUMBER: (B)(4). THIS COMPLAINT WAS PREVIOUSLY INCORRECTLY REPORTED UNDER 2027971-2019-00016 AS A MANUFACTURER REPORT. THE MEDICAL DEVICE WAS HOWEVER NOT MANUFACTURED BUT IMPORTED BY (B)(4) UNDER SITE REGISTRATION NUMBER 2027971. THE MEDICAL DEVICE WAS ACTUALLY MANUFACTURED UNDER SITE REGISTRATION NUMBER 9611993, AND THEREFORE REPORTED IN THIS MANUFACTURERS REPORT. A FOLLOW UP REPORT WILL BE SUBMITTED FOR 2027971-2019-00016, CHANGING THE REPORT TO AN UF/IMPORTER REPORT.

Description of Event or Problem

ISSUE DESCRIPTION AN ORIGINAL BRANEMARK WAS PLACED IN 1992 WITH A LOWER HYBRID BRIDGE IN FIVE IMPLANTS. IMPLANT ON POSITION #28 HAD 50% BONELOSS AND WAS REMOVED, REPLACED BY A BRÅNEMARKSYST MKIII GROOVY RP3.75X11.5MM ON (B)(6) 2019. THE CUSTOMER REPORTED TO NOBEL BIOCARE THAT ON (B)(6) 2019 THE PATIENT EXPERIENCED OSTEOMYELITIS OF THE MANDIBLE. THE FIXTURE WAS REMOVED AND THE PATIENT RECEIVED SIX WEEKS OF ANTIBIOTICS AND HAD A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE PLACED. THE PATIENT WAS FULLY RECOVERED WHEN CHECKED POST OPERATION ON (B)(6) 2019. THE RETURNED PRODUCT WAS RECEIVED OPENED AND USED. VISUAL INSPECTION AND MEASUREMENT OF THE RETURNED PRODUCT SHOWS THAT THE PRODUCT INFORMATION PROVIDED BY THE CUSTOMER IS CORRECT. THE INJURY AS DESCRIBED MAY HAVE BEEN CAUSED BY FAILURE TO FOLLOW PROCEDURES. THIS BATCH, 674471, WAS EXPIRED ON 14-JANUARY-2012, AS INDICATED ON THE LABEL.