GRAFTON DBM

Description of Event or Problem

PATIENT STATED THAT HE HAD RECEIVED ALLOGRAFT BONE VOID FILLER TO "FILL THE VOID IN THE CAGE" DURING AN ACDF SPINAL SURGERY IN (B)(6) 2010, AND THAT HE IS CURRENTLY (APPROX 37 MONTHS POST-OP) EXPERIENCING PAIN, AND WAS RECENTLY DIAGNOSED WITH "SOME SORT OF AUTOIMMUNE CONDITION THAT MAY OR MAY NOT BE RELATED" TO HIS IMPLANT. PATIENT DID NOT REPORT HAVING HAD ANY REVISION PROCEDURE FOLLOWING THE INITIAL SURGERY. HE WENT ON TO SAY THAT "DEVICES AND BIOLOGICS CAN MANIFEST INFECTIONS AT ANY GIVEN TIME," AND SUGGESTED THAT WAS PART OF HIS PROBLEM. HE DENIED HAVING HAD ANY FEVER OR INFECTION POST-OPERATIVELY, HOWEVER, STATING HE WAS HAVING "WEIRD SYMPTOMS" THAT NO ONE COULD EXPLAIN, INCLUDING CONTINUED ACHES AND PAINS IN HIS NECK.

Additional Manufacturer Narrative

THIS MEDWATCH REPORT WAS COMPLETED USING THE INFORMATION PROVIDED BY THE INITIAL REPORTER. ANY MISSING OR INCOMPLETE DATA IS THE RESULT OF THE INFORMATION NOT HAVING BEEN PROVIDED BY THE INITIAL REPORTER. (B)(4). REVIEW OF MANUFACTURING RECORDS INDICATED THAT THE PRODUCT WAS MANUFACTURED PER PROCEDURE AND MET ALL REQUIRED SPECIFICATIONS. MEDTRONIC HAS NOT RECEIVED ANY ADDITIONAL REPORTS OF THIS NATURE INVOLVING ANY OTHER GRAFTS MANUFACTURED IN THE SUBJECT LOT, OR FROM THIS DONOR TISSUE. THE MANUFACTURER'S MEDICAL DIRECTOR HAS CONCLUDED THAT THE PROCESSED DONOR TISSUE IS IMMUNOLOGICALLY INERT, AND WOULD NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S SELF-REPORTED AUTOIMMUNE SYMPTOMS. THE SUBJECT PRODUCT WAS PART OF THE ABOVE-REFERENCED VOLUNTARY RECALL.