XIA TITANIUM 4.5 VITALIUM ROD 4.5 X 600 MM
Received Mar 8, 2018 · Event occurred Feb 12, 2018
Report 0009617544-2018-00064 · MDR key 7323863
Device
Generic name
Thoracolumbosacral Pedicle Screw System.
Manufacturer
Stryker Spine-usModel number
48132601Catalog number
48132601
Lot number
UNKNOWN
Product problems
- Fracture
- Break
- Fracture
Patient
Not reported
- Injury
- No Known Impact Or Consequence To Patient
- Injury
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE ROD BROKE.
Additional Manufacturer Narrative
THE REPORTED EVENT RESULTED IN PATIENT REVISION SURGERY. METHOD: RISK ASSESSMENT; X-RAYS. RESULTS: VISUAL, DIMENSIONAL AND FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. NO LOT # WAS PROVIDED, SO A MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED. CONCLUSION: THE RODS WERE FOUND FRACTURED ABOUT 9 MONTHS AFTER THE ORIGINAL SURGERY. FUSION DID NOT OCCUR. THE X RAY SHOWS SEVERAL LEVELS OF FIXATION AT THE TOP OF THE CONSTRUCT, AND SEVERAL LEVELS OF FIXATION AT THE BOTTOM, AND A SECTION OF NON FIXATION IN THE MIDDLE. THIS, ALONG WITH THE CURVATURE OF THE SPINE, COULD CAUSE A BENDING MOMENT. OVER TIME THIS COULD CAUSE THE RODS TO FRACTURE DUE TO THE STRESS AND STRAIN OF THE CONSTRUCT. HOWEVER SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION THE DEFINITE ROOT CAUSE CANNOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT THE ROD BROKE.