GRAFTON DBM
Received May 22, 2014
Report 2246640-2014-00004 · MDR key 3828204
Device
Generic name
Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
Manufacturer
Osteotech, Inc (subsidiary Of Medtronic)Model number
NOT REPORTEDCatalog number
NOT REPORTED
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Pain
- Complaint, Ill-Defined
Narrative
Description of Event or Problem
A PATIENT REPORTED THAT SHE RECEIVED ALLOGRAFT BONE VOID FILLER DURING HER CERVICAL SPINE FUSION PROCEDURE IN 2007 AND STATES THAT SHE IS CURRENTLY HAVING ¿DIFFICULTY SWALLOWING, NERVE PAIN (C6-C7 NERVE ROOT) AND CHRONIC SYMPTOMS WITH DECREASED MOBILITY.¿ THE PATIENT DID NOT PROVIDE ANY SPECIFIC PRODUCT OR LOT INFORMATION. THE PATIENT DENIED HAVING HAD ANY POST-OPERATIVE INFECTION OR REVISION PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
NO MEDWATCH FORM WAS RECEIVED FROM THE USER FACILITY, THEREFORE, THIS MEDWATCH WAS COMPLETED USING THE INFORMATION PROVIDED BY THE INITIAL REPORTER. ANY MISSING OR INCOMPLETE INFORMATION IS THE RESULT OF THE INFORMATION NOT HAVING BEEN PROVIDED BY THE INITIAL REPORTER. (B)(4).