GRAFTON PLUS DBM PASTE
Received Dec 17, 2010 · Event occurred Jan 1, 2010
Report 2246640-2010-00003 · MDR key 1943744
Device
Generic name
Bone Void Filler, Osteoinductive
Manufacturer
Osteotech, Inc.Model number
UNKCatalog number
UNK
Lot number
UNK
Product problems
- Patient-Device Incompatibility
Patient
Not reported
- Inflammation
- Reaction
- Fluid Discharge
Narrative
Description of Event or Problem
ON (B)(6) 2010, A DISTRIBUTOR OUTSIDE OF THE U.S. REPORTED THAT A PT, WHO HAD UNDERGONE A "SCOLIOSIS-RELATED DEFORMITY CORRECTION" IN (B)(6) 2010 USING GRAFTON PASTE, HAD EXPERIENCED A POST-OPERATIVE INFLAMMATORY REACTION WITH "LOCAL OOZING FROM THE WOUND". NO ADD'L DETAILS ABOUT THE CASE WERE KNOWN OR PROVIDED BY THE INITIAL REPORTER. NO LOT INFO WAS PROVIDED. A LIST OF DETAILED F/U QUESTIONS HAS BEEN SUBMITTED TO THE INITIAL REPORTER, AND WE HAVE MADE MULTIPLE UNSUCCESSFUL F/U ATTEMPTS WITH THE DISTRIBUTOR TO OBTAIN THE INFO (ON (B)(6) 2010). IT IS UNK AT THIS TIME IF THE EVENT NECESSITATED ANY SUBSEQUENT MEDICAL OR SURGICAL INTERVENTION.