RIALTO SI FUSION SYSTEM
Received Mar 8, 2016
Report 1030489-2016-00633 · MDR key 5485459
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Unspecified Infection
- Pain
- Osteolysis
- Unspecified Infection
- Pain
- Osteolysis
Narrative
Additional Manufacturer Narrative
(B)(). NEITHER THE PRODUCT NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER,THEREFORE CAUSE OF EVENT CANNOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED PATIENT UNDERWENT SACROILIAC JOINT FUSION WITH SPINAL SCREW SYSTEM ON (B)(6) 2015.ON AN UNKNOWN DATE, POST-OP, PATIENT ALLEGED THAT SHE HAD A "BONE INFECTION" AT THE SITE OF ONE OF THE SCREWS AND BONE LOSS AT THAT SITE.PATIENT UNDERWENT REVISION ON (B)(6) 2015 IN WHICH SCREW WAS REMOVED AND IV ANTIBIOTIC THERAPY WAS NEEDED FOR SEVERAL WEEKS. PATIENT CLAIMED THAT PATHOLOGY REPORT DID NOT INDICATE THERE WAS AN INFECTION BUT SED RATE WAS ELEVATED.
Additional Manufacturer Narrative
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
AS PER PATIENT CALL, THE PATIENT REPORTED THAT SHE DEVELOPED INCREASED PAIN AND VERY LOW INTERMITTENT FEVER ABOUT 2 WEEKS AFTER. IT WAS FIRST THOUGHT TO BE A HEMATOMA. A CT SCAN WAS DONE AND SHOWED AGGRESSIVE BONE LOSS AND LUCENCY ESPECIALLY AROUND ONE OF THE SCREWS. PATIENT WAS HOSPITALIZED FOR A WEEK AND REVISION SURGERY WAS ON (B)(6) TO REMOVE ONE OF THE SCREWS AND CLEAN OUT THE WOUND. SAMPLES WERE TAKEN BUT NOTHING "GREW". PATIENT IS STILL ON PAIN MEDS TO GET THROUGH THE DAY. PATIENT JOINT, PIRIFORMIS IS WORSE THAN BEFORE SURGERY. PATIENT ALSO UNDERWENT CT SCANS WHICH SHOWED NO SIGNS OF RADIOLOGICAL IN THE SI JOINT. THE PATIENT IS BEING TESTED AND HER SI JOINT ASPIRATED WHERE THE INFECTION WAS DUE TO STILL HAVING SYMPTOMS AND THE PROSPECT OF A REVISION SURGERY.