PROGENIX
Received Jun 19, 2013
Report 1030489-2013-02360 · MDR key 3177129
Device
Generic name
Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
Manufacturer
Medtronic Sofamor Danek Instrument ManufacturingModel number
NACatalog number
006001
Lot number
1486900056
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Hypersensitivity/Allergic reaction
- Skin Irritation
- Swelling
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT HAS HAD SOME ALLERGIC REACTIONS ALONG WITH TONGUE SWELLING AND SKIN REACTIONS AFTER AN UNSPECIFIED SPINAL SURGERY. PRODUCT IS CONTRAINDICATED AND SHOULD NOT BE USED BY INDIVIDUALS WITH ALLERGIES TO BACITRACIN. NO FURTHER INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
(B)(4). THE PRODUCT WAS NOT 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.