PROGENIX PLUS
Received May 10, 2011
Report 1030489-2011-00534 · MDR key 2083581
Device
Generic name
Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
Manufacturer
Medtronic Sofamor DanekCatalog number
006005
Lot number
1252010109
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. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL PROCEDURE TO TREAT SCOLIOSIS AND SPONDYLOLYSIS USING DEMINERALIZED BONE MATRIX. POST-OP, THE PATIENT DEVELOPED AN INFECTION IN THE SPINE. THE PATIENT UNDERWENT A REVISION SURGERY TEN DAYS POST-OP TO REMOVE THE DEVICE.
Description of Event or Problem
THE PATIENT HAD AN EXTENSIVE INFECTION THAT RESULTED IN THE PATIENT GOING BACK TO THE OR EIGHT TIMES FOR IRRIGATION AND DEBRIDEMENT AND THEN A COMPLEX CLOSING. CULTURES OF THE SITE GREW E.COLI. THE PATIENT IS STILL ON CIPRO AND IS BEING SEEN AT AN INFECTIONS DISEASE CLINIC.