GRAFTON DBM
Received Dec 4, 2013
Report 2246640-2013-00028 · MDR key 3499801
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
Lot number
NOT REPORTED
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Pain
Narrative
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)(6). (B)(4). NO REVIEW OF THE APPLICABLE DEVICE HISTORY RECORDS WAS POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION. NO TRENDS IN REPORTS OF THIS NATURE HAVE BEEN IDENTIFIED. A DEFINITIVE CAUSE FOR THE REPORTED EVENT CANNOT, THEREFORE, BE DETERMINED.
Description of Event or Problem
PATIENT CONTACTED THE MANUFACTURER AND STATED THAT SHE HAD RECEIVED ALLOGRAFT BONE VOID FILLER DURING A CERVICAL FUSION (C4-C6) IN (B)(6), 2012, AND 16 MONTHS POST-OP REPORTS HAVING "KNOTS AND PAIN" AND "BONE SPURS" IN HER NECK. NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED. PATIENT DID NOT PROVIDE ANY ADDITIONAL INFORMATION.