InjuryMBP
N/A
Received Nov 4, 2014
Report 1030489-2014-04205 · MDR key 4224198
Device
Generic name
Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
Manufacturer
Medtronic Sofamor Danek Usa, IncModel number
NACatalog number
006010
Lot number
1935950104
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 APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
IT WAS REPORTED THAT AFTER AN UNSPECIFIED SPINAL SURGERY, A PATIENT HAD INFECTION POST-OPERATIVELY.