GRAFTON DBM
Received Jul 14, 2014
Report 2246640-2014-00008 · MDR key 3932677
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
- Device Operates Differently Than Expected
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A SURGEON HAD STOPPED USING THE ALLOGRAFT BONE VOID FILLER PRODUCT AS A RESULT OF 'DRAINING ISSUES' WHICH HE IS ATTRIBUTING TO THE PRODUCT. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, THOUGH NONE WAS PROVIDED. IT IS NOT KNOWN WHETHER ANY MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED.
Additional Manufacturer Narrative
NEITHER THE DEVICE NOR ANY PATIENT MEDICAL RECORDS OR IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PART NUMBER OR LOT INFORMATION WAS PROVIDED; THEREFORE, NO REVIEW OF THE DEVICE HISTORY RECORDS WAS POSSIBLE. THE MANUFACTURER IS UNABLE TO EVALUATE OR DETERMINE A DEFINITIVE CAUSE FOR THE REPORTED EVENT.