PROGENIX DBM PUTTY

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT DEVELOPED A DEEP SURGICAL WOUND INFECTION FOLLOWING POSTEROLATERAL LUMBAR SPINAL IMPLANTATION OF THE DEMINERALIZED BONE MATRIX PUTTY FOR TREATMENT OF SCOLIOSIS. CULTURES FOUND THAT THE COLONIZING ORGANISM WAS STAPHYLOCOCCUS AUREUS (NON-MRSA). A SURGICAL INTERVENTION WAS PERFORMED AT AN UNKNOWN TIME POST-OP IN 2008 TO IRRIGATE AND DEBRIDE THE SURGICAL WOUND. CULTURES FROM THE WOUND ALSO GREW STAPH AUREUS.

Additional Manufacturer Narrative

NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. THE REPORTED INFECTING AGENT IS A COMMON NOSOCOMIAL CONTAMINANT, AND THIS DEVICE WAS PROVIDED STERILE. THE REPORTED EVENT IS BELIEVED TO BE A COMPLICATION ASSOCIATED WITH THE SURGICAL PROCEDURE, WHICH WAS UNRELATED TO THIS DEVICE. NEVERTHELESS, WE ARE SUBMITTING THIS MEDWATCH FOR NOTIFICATION PURPOSE.