InjuryMBP
FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)
Received Aug 9, 2012
Report 1030489-2012-01359 · MDR key 2688588
Device
Generic name
Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
Manufacturer
Medtronic Sofamor Danek Usa, IncModel number
NACatalog number
UNKNOWN
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Cyst(s)
- Nonunion/Delayed-union Bone Fracture
Narrative
Additional Manufacturer Narrative
(B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.
Description of Event or Problem
IT WAS REPORTED THAT THE LATERAL GUTTERS HAD A CYSTIC APPEARANCE AND THAT A NON UNION HAPPENED.