PROGENIX DBM PUTTY

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH DEMINERALIZED BONE MATRIX PUTTY, AND THAT THE PATIENT SUBSEQUENTLY DEVELOPED A POST OPERATIVE INFECTION THAT THE SURGEON IS ATTRIBUTING TO THE PUTTY. THE GRAFT REMAINS IMPLANTED IN THE PATIENT. THE SURGEON HAS BEEN UNAVAILABLE TO PROVIDE ADDITIONAL DATA REGARDING THIS CASE, AND THE TREATMENT OF THE EVENT IS UNKNOWN.

Additional Manufacturer Narrative

A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS LOT DID NOT REVEAL ANY NON-CONFORMANCE'S TO SPECIFICATION, OR PROCESS DEVIATIONS WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. ADDITIONALLY, THE SURGEON HAS BEEN UNAVAILABLE TO PROVIDE ADDITIONAL DATA REGARDING THIS CASE, AND THEREFORE, WE ARE UNABLE TO DETERMINE WHETHER THE REPORTED INFECTION IS DEVICE RELATED. NEVERTHELESS, WE ARE FILING THIS REPORT FOR NOTIFICATION PURPOSES.