XIA 3 TITANIUM MULTIAXIAL CROSSLINK 28MM 31MM
Received Oct 9, 2014 · Event occurred Sep 10, 2014
Report 0009617544-2014-00434 · MDR key 4154880
Device
Product problems
- Break
- Positioning Problem
Patient
70 YR
- No Code Available
Narrative
Description of Event or Problem
IT WAS REPORTED THAT REVISION SURGERY PERFORMED TO REPAIR A PSEUDOARTHROSIS AND USED A SIDE BY SIDE CONNECTOR. PATIENT BROUGHT IN FOR SURGERY BECAUSE X-RAY SHOWED THE ROD WAS NOT ENGAGED IN TULIP HEAD OF CONNECTOR. THE DR. DECIDED TO REPLACE THE ENTIRE ROD FROM T4-PELVIS. UPON EXPOSURE ALSO NOTICE THE MAC CONNECTOR HAD BROKEN (ORIGINALLY IMPLANTED A YEAR AGO).
Additional Manufacturer Narrative
METHOD: DEVICE HISTORY REVIEW AND DEVICE EVALUATION. RESULTS: NO MANUFACTURING ISSUES WERE IDENTIFIED. VISUAL INSPECTION NOTED THE RETURNED CROSS CONNECTOR WAS CONFIRMED TO BE FRACTURED AT THE NECK CLOSEST TO ONE OF THE HOOKS. THE CONNECTOR HAD MULTIPLE SCRATCHES AND INDENTATIONS PRESENT. THE SET SCREW WAS RECEIVED UNTHREADED FROM THE HOOK. MATERIAL ANALYSIS NOTED THE MULTI-AXIAL CROSSLINK WAS FOUND TO HAVE FRACTURED IN FATIGUE. HEAVY DAMAGE ON THE SURFACE PREVENTED THE DETERMINATION OF THE ORIGIN AND PROGRESSION. THE MATERIAL WAS FOUND TO CONFORM TO THE MATERIAL LISTED ON THE PRINT. NO MATERIAL OR MANUFACTURING DEFECTS WERE FOUND. CONCLUSION: IT WAS DETERMINED THAT THE DEVICE BROKE THROUGH FATIGUE AND THAT NO MATERIAL OR MANUFACTURING DEFECTS WERE FOUND. THE MOST LIKELY CAUSE OF THE CUSTOMER REPORTED EVENT IS FATIGUE OF THE DEVICE WITH THE LENGTH OF IMPLANTATION CONTRIBUTING TO THE EVENT.
Description of Event or Problem
IT WAS REPORTED THAT REVISION SURGERY PERFORMED TO REPAIR A PSEUDOARTHROSIS AND USED A SIDE BY SIDE CONNECTOR. PATIENT BROUGHT IN FOR SURGERY BECAUSE X-RAY SHOWED THE ROD WAS NOT ENGAGED IN TULIP HEAD OF CONNECTOR. THE DR. DECIDED TO REPLACE THE ENTIRE ROD FROM T4-PELVIS. UPON EXPOSURE ALSO NOTICE THE MAC CONNECTOR HAD BROKEN (ORIGINALLY IMPLANTED A YEAR AGO).