XEMFLIFI DBM PLUS, 3CC
Received Aug 7, 2015 · Event occurred Mar 13, 2015
Report 3004142400-2015-00032 · MDR key 4990515
Device
Product problems
- Insufficient Device Problem Information
Patient
50 YR
- Abscess
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. A THOROUGH INVESTIGATION WAS COMPLETED, AND NO DEVIATIONS TO PROCESSING WERE IDENTIFIED. THERE HAVE BEEN NO PREVIOUS REPORTED ISSUES OF THIS TYPE. XEMPLIFI PLUS IS A STERILE PACKAGED PRODUCT. STERILITY CAN BE ASSURED AS LONG AS THE PRODUCT PACKAGE IS NOT COMPROMISED. IN THIS CASE, THERE WAS NO REPORTED ISSUES WITH THE STERILITY OF THE PRODUCT. POSTOPERATIVE INFECTION CAN BE CAUSED FROM A WIDE VARIETY OF SOURCES. IN THIS EVENT, IT IS NOT POSSIBLE TO DETERMINE THE EXACT CAUSE OF THE INFECTION. THIS REPORT IS ASSOCIATED WITH MDR (B)(4).
Description of Event or Problem
IT WAS REPORTED TO GLOBUS THAT A PATIENT HAD A FUSION SURGERY C5-6 ON (B)(6) 2016 AT (B)(6) HOSPITAL (B)(6). THE PATIENT LATER DEVELOPED AN ABSCESS/INFECTION, AND HAD TO HAVE THE SPINAL HARDWARE, COALITION SPACER, AND XEMPLIFI PUTTY REMOVED. THE REMOVAL SURGERY TOOK PLACE (B)(6) 2015. THE REMOVAL SURGERY WAS PERFORMED AT (B)(6) HOSPITAL (B)(6). THE REMOVAL SURGERY WAS PERFORMED BY DIFFERENT SURGEON THAN THE INITIAL SURGERY.