InjuryNPZ
INFUSE BONE GRAFT
Received Dec 30, 2015
Report 1030489-2015-03618 · MDR key 5335709
Device
Generic name
Bone Grafting Material, Dental, With Biologic Component
Manufacturer
Medtronic Sofamor Danek Usa, IncModel number
NACatalog number
7510050
Lot number
ML80484AAE
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Unspecified Infection
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 ON AN UNKNOWN DATE, POST-OP, PATIENT HAD INFECTION. THE PRODUCT CAME IN CONTACT WITH THE PATIENT.