GRAFTON DBM PUTTY
Received Jun 22, 2012 · Event occurred Mar 8, 2012
Report 2246640-2012-00018 · MDR key 2634051
Device
Generic name
Demineralized Bone Matrix Allograft
Manufacturer
Osteotech, Inc.Catalog number
NO REPORTED
Lot number
NOT REPORTED
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Nonunion/Delayed-union Bone Fracture
Narrative
Description of Event or Problem
PODIATRIST REPORTED THAT HE IMPLANTED BONE VOID FILLER GRAFT IN A PT DURING AN ANKLE JOINT PROCEDURE AND THE PT DEVELOPED A NON-UNION. DATE OF ORIGINAL SURGERY WAS NOT REPORTED. IT WAS REPORTED THAT THE DR USED A BONE STIMULATOR AND PLACED THE PT IN AN EXTERNAL FIXATOR IMMEDIATELY FOLLOWING THE PROCEDURE. NO ADD'L PT OR CLINICAL INFO WAS PROVIDED.
Additional Manufacturer Narrative
THIS MEDWATCH FORM WAS COMPLETED WITH THE INFO PROVIDED BY THE INITIAL REPORTER. ANY MISSING OR INCOMPLETE DATA IS THE RESULT OF THE INFO NOT HAVING BEEN PROVIDED BY THE INITIAL REPORTER. NO REVIEW OF MFG RECORDS FOR THE SUBJECT GRAFT WAS POSSIBLE WITHOUT ADD'L DEVICE INFO. NO X-RAYS OR IMAGING STUDIES WERE PROVIDED. WE ARE THEREFORE, UNABLE TO DETERMINE A DEFINITIVE CAUSE FOR THE REPORTED EVENT. NO FURTHER ACTION IS REQUIRED, AND THIS INCIDENT IS CONSIDERED CLOSED.