PLEXUR P

Description of Event or Problem

IT WAS REPORTED THAT THE SURGEON IMPLANTED THE BONE VOID FILLER DURING A MAXILLOMANDIBULAR ADVANCEMENT (LE FORT I OSTEOTOMY). THE DATE OF SURGERY WAS NOT REPORTED. AT 7 TO 8 MONTHS POST-OPERATIVELY (THE EXACT DATE WAS NOT REPORTED), THE SURGEON REPORTED THAT THERE WERE AREAS WHERE NEW BONE HAD NOT FORMED. THE SURGEON PERFORMED A REVISION PROCEDURE ON THE PT, FILLING THESE AREAS USING ILIAC CREST BONE GRAFT.

Additional Manufacturer Narrative

THIS REPORT WAS COMPLETED USING THE INFO RECEIVED FROM THE HEALTHCARE PROFESSIONAL. ANY MISSING OR INCOMPLETE DATA IS THE RESULT OF THE INFO NOT HAVING BEEN PROVIDED BY THE REPORTER. OSTEOTECH'S ATTEMPTS TO OBTAIN ADDITIONAL INFO FROM THE REPORTER WERE UNSUCCESSFUL. ALL MFG RECORDS FOR THE SUBJECT GRAFT WERE REVIEWED, AND INDICATED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO PROCEDURE AND MET ALL SPECIFICATIONS. ALL CRITICAL PROCESSING PARAMETERS WERE MET, AND THERE WERE NO IRREGULARITIES OR NON-CONFORMANCES ASSOCIATED WITH THIS PROCESSING OF THE PRODUCT. THERE HAVE BEEN NO ADDITIONAL REPORTS OF THIS NATURE ASSOCIATED WITH PRODUCTS PRODUCED FROM THIS DONOR. THE SURGEON, IN THIS CASE, REPORTEDLY STATED THAT HE HAD NO CONCERNS REGARDING THE PRODUCT, AND THAT THE MANNER IN WHICH HE HAD CLOSED THE SURGICAL SITE COULD HAVE COMPROMISED THE HEALING.